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Klinická studie zkoumající bezpečnost a účinnost přípravku AP-Brain na kognitivní funkce při různých dávkách u zdravých mladších dospělých s vlastním hlášením problémů s pozorností

11. listopadu 2026 aktualizováno: Rousselot BVBA

Randomizovaná, trojitě zaslepená, placebem kontrolovaná, paralelní, proof-of-concept klinická studie pro zkoumání bezpečnosti a účinnosti AP-Brain na kognitivní funkce při různých dávkách u zdravých mladších dospělých s vlastním hlášenými problémy s pozorností

The goal of this clinical trial is to investigate the safety and efficacy of AP-Brain on cognitive function at varying dosages in healthy younger adults with self-reported attention problems.

The main question it aims to answer is what Change from baseline to Day 56 between AP-Brain (1g, 3g, or 5g) and placebo in cognitive function, as assessed by the CNS VS Neurocognitive Index (NCI) score and complex attention.

Participants will be asked to consume AP-Brain at 1 g, 3 g, or 5g, or Placebo and asked to complete memory assessment questionnaires.

Přehled studie

Postavení

Postavení

Označuje aktuální stav náboru nebo stav rozšířeného přístupu.
Nábor

Podmínky

Podmínky

Nemoc, porucha, syndrom, nemoc nebo zranění, které je studováno. Na webu ClinicalTrials.gov mohou podmínky zahrnovat i další problémy související se zdravím, jako je délka života, kvalita života a zdravotní rizika.

Intervence / Léčba

Intervence / Léčba

Proces nebo akce, na které se klinická studie zaměřuje. Intervence zahrnují léky, zdravotnická zařízení, postupy, vakcíny a další produkty, které jsou buď zkoušené nebo již dostupné. Intervence mohou také zahrnovat neinvazivní přístupy, jako je edukace nebo úprava stravy a cvičení.

Typ studie

Typ studie

Popisuje povahu klinické studie. Typy studií zahrnují intervenční studie (také nazývané klinické studie), observační studie (včetně registrů pacientů) a rozšířený přístup.
Intervenční

Zápis (Odhadovaný)

Zápis

Počet účastníků klinické studie. „Očekávaný“ zápis je cílový počet účastníků, které výzkumníci pro studii potřebují.
120

Fáze

Fáze

Fáze klinické studie studující lék nebo biologický produkt na základě definic vyvinutých americkým Úřadem pro kontrolu potravin a léčiv (FDA). Fáze je založena na cíli studie, počtu účastníků a dalších charakteristikách. Existuje pět fází: časná fáze 1 (dříve uváděná jako fáze 0), fáze 1, fáze 2, fáze 3 a fáze 4. Nepoužitelný se používá k popisu zkoušek bez fází definovaných FDA, včetně zkoušek zařízení nebo behaviorálních intervencí.
  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní kontakt

Jméno a kontaktní údaje osoby, která může odpovědět na otázky týkající se registrace do klinické studie. Každé místo, kde se studie provádí, může mít také konkrétní kontakt, který může lépe odpovědět na tyto otázky.

Studijní místa

  • Kanada
    • Ontario
      • London, Ontario, Kanada, N6B3L1
        • Nábor
        • KGK Science Inc.
        • Kontakt:
      • London, Ontario, Kanada, N6B3L1
        • Zatím nenabíráme
        • KGK Science Inc.
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Kritéria způsobilosti

Klíčové požadavky, které musí lidé, kteří se chtějí zúčastnit klinické studie, splňovat nebo vlastnosti, které musí mít. Kritéria způsobilosti se skládají jak z kritérií pro zařazení (která jsou vyžadována pro účast osoby ve studii), tak z kritérií vyloučení (která brání osobě v účasti). Typy kritérií způsobilosti zahrnují, zda studie přijímá zdravé dobrovolníky, má požadavky na věk nebo věkovou skupinu nebo je omezena pohlavím.

Věk způsobilý ke studiu

18 let až 39 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  1. Males and females 18-39 years of age, inclusive

  2. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening

    Or,

    Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

    • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
    • Double-barrier method
    • Intrauterine devices
    • Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
    • Vasectomy of partner at least 6 months prior to screening
    • Abstinence and agrees to use contraception if planning on becoming sexually active

  3. Individuals with self-reported focus or attention problems, as determined by QI assessment of the Adult Attention Deficit Hyperactivity Disorder Self-Report Scale (Part A) (ASRS; version 1.1) (20)

  4. Agrees to avoid high sources of caffeine (e.g., supplements, tea, coffee, energy drinks), NSAIDs, and alcohol consumption for 24 hours prior to post-screening clinic visits

  5. Agrees to avoid first generation anti-allergy medication for 48 hours prior to post-screening clinic visits

  6. Agrees to avoid moderate-vigorous exercise 12 hours prior to post-screening clinic visits

  7. Agrees to avoid travel across two or more time zones two weeks prior to any study visit

  8. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study

  9. Willing and able to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits

  10. Provided voluntary, written, informed consent to participate in the study

  11. Healthy as determined by medical history, laboratory results, and vital signs, as assessed by the QI

Exclusion Criteria:

  1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
  2. Allergy, sensitivity, or intolerance to the investigational product or placebo ingredients
  3. Clinical diagnosis and/or prescribed treatment for ADHD (See Section 7.3.1)
  4. Self-reported confirmation of any significant neuropsychological condition and/or cognitive impairment (e.g., autism spectrum disorder, schizophrenia, bipolar disorder, post-traumatic stress disorder, brain injury, neurodegenerative disease, infections, insomnia, depression, epileptic or other seizure-related disorders) that could interfere with study participation as assessed by the QI
  5. Self-reported color blindness/weakness as assessed by the QI
  6. Individuals who consume high caffeine daily or are addicted to caffeine at screening as assessed by the QI
  7. Current employment that calls for overnight shiftwork as assessed by the QI
  8. Unstable metabolic disease or chronic diseases as assessed by the QI
  9. Current or history of significant diseases of the gastrointestinal tract or conditions that result in malabsorption, as assessed by the QI
  10. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3.1)
  11. Type I diabetes
  12. Type II diabetes if on insulin treatment. Type II diabetics on stable medication for at least three months and an HbA1c of <8.0% may be included after assessment by the QI on a case-by-case basis
  13. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
  14. History of or current diagnosis with kidney, gallbladder (e.g., gallstones, bile duct obstruction), and/or liver diseases (e.g., reduced bile salts, SIBO) as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
  15. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
  16. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
  17. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
  18. Individuals with an autoimmune disease or are immune compromised as assessed by the QI
  19. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
  20. Self-reported confirmation of blood/bleeding disorders as assessed by QI
  21. Use of medical cannabinoid products
  22. Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
  23. Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
  24. Alcohol intake average of >2 standard drinks per day as assessed by the QI
  25. Alcohol or drug abuse within the last 12 months
  26. Current use of prescribed and/or OTC medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Sections 7.3.1 and 7.3.2)
  27. Current or previous use of cognitive training programs or therapies, as assessed by the QI
  28. Clinically significant abnormal laboratory results at screening as assessed by the QI
  29. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
  30. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
  31. Individuals who are cognitively impaired and/or unable to give informed consent
  32. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm

Skupina účastníků / Arm

Skupina nebo podskupina účastníků klinické studie, která podle protokolu studie dostává konkrétní intervenci/léčbu nebo žádnou intervenci.
Intervence / Léčba

Intervence / Léčba

Proces nebo akce, na které se klinická studie zaměřuje. Intervence zahrnují léky, zdravotnická zařízení, postupy, vakcíny a další produkty, které jsou buď zkoušené nebo již dostupné. Intervence mohou také zahrnovat neinvazivní přístupy, jako je edukace nebo úprava stravy a cvičení.
Experimentální: AP-Brain (1g)

AP-Brain (1g) contains 1 g of hydrolyzed collagen in a capsule
Doplněk stravy: AP-Brain (1g)

Participants will be instructed to take one dose (5 tablets) of the study product with a standardized meal during their in-clinic visit. This group will receive 1 APBrain capsule and 4 placebo capsules.
Experimentální: AP-Brain (3g)

AP-Brain (3 g) contains 3 g of hydrolyzed collagen in a capsule
Doplněk stravy: AP-Brain (3g)

Participants will be instructed to take one dose (5 tablets) of the study product with a standardized meal during their in-clinic visit. This group will receive 3 APBrain capsules and 2 placebo capsules
Experimentální: AP-Brain (5g)

AP-Brain (5 g) contains 5 g of hydrolyzed collagen in a capsule
Doplněk stravy: AP-Brain (5g)

Participants will be instructed to take one dose (5 tablets) of the study product with a standardized meal during their in-clinic visit. This group will receive 5 APBrain capsules and 0 placebo capsules
Komparátor placeba: Placebo

Placebo consists of Silicified Microcrystalline Cellulose, magnesium stearate, Hydroxypropyl cellulose, and titanium dioxide
Doplněk stravy: Placebo

Participants will be instructed to take one dose (5 tablets) of the study product with a standardized meal during their in-clinic visit. This group will receive 0 AP-Brain capsules and 5 placebo capsules.

Co je měření studie?

Primární výstupní opatření

Primární výstupní opatření

V protokolu klinické studie je plánovaná výsledná míra, která je nejdůležitější pro hodnocení účinku intervence/léčby. Většina klinických studií má jedno primární měřítko výsledku, ale některé mají více než jedno.
Měření výsledku
Popis opatření
Časové okno
Change from baseline to Day 56 between AP-Brain and placebo in cognitive function, as assessed by the CNS VS Neurocognitive Index (NCI) score
Časové okno: Day 0 to 56

Change from baseline to Day 56 between AP-Brain and placebo in cognitive function, as assessed by the CNS VS Neurocognitive Index (NCI) score and complex attention. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domain
Day 0 to 56

Sekundární výstupní opatření

Sekundární výstupní opatření

V protokolu klinické studie jde o plánované měřítko výsledku, které není tak důležité jako primární měřítko výsledku pro hodnocení účinku intervence, ale je stále zajímavé. Většina klinických studií má více než jedno sekundární měřítko výsledku.
Měření výsledku
Popis opatření
Časové okno
Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in NCI Score as assessed by the CNS VS Neurocognitive Index (NCI) score.
Časové okno: Day 0 and 1

Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: NCI Score. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 1
Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in NCI Score assessed via CNS VS test battery.
Časové okno: Day 0 and 56

Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in the following CNS VS measures: NCI Score. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 56
Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in Complex attention via CNS VS test battery
Časové okno: Day 0 and 1

Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: Complex attention. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 1
Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in Verbal, visual, composite, and working memory assessed via CNS VS test battery.
Časové okno: Day 0 and 1

Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: Verbal, visual, composite, and working memory. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 1
Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in the following CNS VS measures: Reaction time assessed via CNS VS test battery.
Časové okno: Day 0 and 56

Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in the following CNS VS measures: Reaction time assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 56
Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: Simple and sustained attention assessed via CNS VS test battery.
Časové okno: Day 0 and 1

Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: Simple and sustained attention assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 1
Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: Executive function assessed via CNS VS test battery.
Časové okno: Day 0 and 1

Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: Executive function assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 1
Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in the following CNS VS measures: Executive function assessed via CNS VS test battery.
Časové okno: Day 0 and 56

Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in the following CNS VS measures: Executive function assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 56
Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: Cognitive flexibility assessed via CNS VS test battery.
Časové okno: Day 0 and 1

Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: Cognitive flexibility assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 1
Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in the following CNS VS measures: Cognitive flexibility assessed via CNS VS test battery.
Časové okno: Day 0 and 56

Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in the following CNS VS measures: Cognitive flexibility assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 56
Change between AP-Brain and placebo in insulin-like growth factor 1 (IGF-1)
Časové okno: Day 0 to 56

Change between AP-Brain and placebo in insulin-like growth factor 1 (IGF-1)
Day 0 to 56
Change from baseline to Day 56 between AP-Brain and placebo in cognitive function, as assessed by complex attention via the CNS VS battery test
Časové okno: Day 0 to 56

Change from baseline to Day 56 between AP-Brain and placebo in cognitive function, as assessed by complex attention. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 to 56
Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in Complex attention via CNS VS test battery
Časové okno: Day 0 and 56]

Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in the following CNS VS measures: Complex attention. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains
Day 0 and 56]
Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in Verbal, visual, composite, and working memory assessed via CNS VS test battery.
Časové okno: Day 0 and 56]

Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in the following CNS VS measures: Verbal, visual, composite, and working memory. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains
Day 0 and 56]
Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: Processing, motor, and psychomotor speed assessed via CNS VS test battery.
Časové okno: Day 0 and 1

Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in Processing, motor, and psychomotor speed assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains
Day 0 and 1
Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in the following CNS VS measures: Processing, motor, and psychomotor speed assessed via CNS VS test battery.
Časové okno: Day 0 and 56

Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in the following CNS VS measures: Processing, motor, and psychomotor speed assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 56
Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: Reaction time assessed via CNS VS test battery.
Časové okno: Day 0 and 1]

Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: Reaction time assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 1]
Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in the following CNS VS measures: Simple and sustained attention assessed via CNS VS test battery.
Časové okno: Day 0 and 56

Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in the following CNS VS measures: Simple and sustained attention assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domain
Day 0 and 56
Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: Impulsivity, defined as a composite score using reaction time, executive function, simple attention, and processing speed domains
Časové okno: Day 0 and 1

Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: Impulsivity, defined as a composite score using reaction time, executive function, simple attention, and processing speed domains assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 1
Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in the following CNS VS measures: Impulsivity, defined as a composite score using reaction time, executive function, simple attention, and processing speed domains.
Časové okno: Day 0 and 56

Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in the following CNS VS measures: Impulsivity, defined as a composite score using reaction time, executive function, simple attention, and processing speed domains assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 56
Change from baseline to Day 28 between AP-Brain and placebo in brain-derived neurotrophic factor (BDNF) Change from baseline to Day 28 between AP-Brain and placebo in brain-derived neurotrophic factor (BDNF)
Časové okno: Day 0 and 28

Change from baseline to Day 28 between AP-Brain and placebo in brain-derived neurotrophic factor (BDNF) Change from baseline to Day 28 between AP-Brain and placebo in brain-derived neurotrophic factor (BDNF)
Day 0 and 28
Change in cognitive function between AP-Brain and placebo based on the following measure: Change from baseline to Day 28 in CNS VS complex attention assessed via CNS VS test battery.
Časové okno: Day 0 and 28

Change in cognitive function between AP-Brain and placebo based on the following measure: Change from baseline to Day 28 in CNS VS complex attention assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 28
Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 28 in the following CNS VS measure: Verbal, visual, composite, and working memory assessed via CNS VS test battery.
Časové okno: Day 0 to 28

Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 28 in the following CNS VS measure: Verbal, visual, composite, and working memory assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 to 28
Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 56 in the following CNS VS measure: Verbal, visual, composite, and working memory assessed via CNS VS test battery.
Časové okno: Day 0 to 56

Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 56 in the following CNS VS measure: Verbal, visual, composite, and working memory assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 to 56
Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 28 in the following CNS VS measure: Processing, motor, and psychomotor speed assessed via CNS VS test battery.
Časové okno: Day 0 to 28

Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 28 in the following CNS VS measure: Processing, motor, and psychomotor speed assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 to 28
Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 56 in the following CNS VS measure: Processing, motor, and psychomotor speed assessed via CNS VS test battery.
Časové okno: Day 0 and 56

Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 56 in the following CNS VS measure: Processing, motor, and psychomotor speed assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 56
Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 28 in the following CNS VS measure: Reaction time assessed via CNS VS test battery.
Časové okno: Day 0 and 28

Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 28 in the following CNS VS measure: Reaction time assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 28
Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 56 in the following CNS VS measure: Reaction time assessed via CNS VS test battery.
Časové okno: Day 0 and 28

Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 56 in the following CNS VS measure: Reaction time assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 28
Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 28 in the following CNS VS measure: Simple and sustained attention assessed via CNS VS test battery.
Časové okno: Day 0 and 28

Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 28 in the following CNS VS measure: Simple and sustained attention assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 28
Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 56 in the following CNS VS measure: Simple and sustained attention assessed via CNS VS test battery.
Časové okno: Day 0 and 56

Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 56 in the following CNS VS measure: Simple and sustained attention assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 56
Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 28 in the following CNS VS measure: Executive function assessed via CNS VS test battery.
Časové okno: Day 0 and 28

Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 28 in the following CNS VS measure: Executive function assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 28
Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 56 in the following CNS VS measure: Executive function assessed via CNS VS test battery.
Časové okno: Day 0 and 56

Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 56 in the following CNS VS measure: Executive function assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 56
Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 28 in the following CNS VS measure: Cognitive flexibility assessed via CNS VS test battery.
Časové okno: Day 0 and 28

Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 28 in the following CNS VS measure: Cognitive flexibility assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 28
Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 56 in the following CNS VS measure: Cognitive flexibility assessed via CNS VS test battery.
Časové okno: Day 0 and 56

Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 56 in the following CNS VS measure: Cognitive flexibility assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 56
Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 28 in the following CNS VS measure: Impulsivity assessed via CNS VS test battery.
Časové okno: Day 0 and 28

Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 28 in the following CNS VS measure: Impulsivity assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 28
Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 56 in the following CNS VS measure: Impulsivity assessed via CNS VS test battery.
Časové okno: Day 0 and 56

Change in cognitive function between AP-Brain and placebo based on change from baseline to Day 56 in the following CNS VS measure: Impulsivity assessed via CNS VS test battery. The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.
Day 0 and 56
Change between AP-Brain and placebo in insulin-like growth factor 1 (IGF-1)
Časové okno: Day 0 and 28

Change between AP-Brain and placebo in insulin-like growth factor 1 (IGF-1)
Day 0 and 28
Change between AP-Brain and placebo between AP-Brain and placebo in markers of inflammation, as assessed by Creactive protein (CRP), tumor necrosis factor alpha (TNF-α), and interleukin (IL)-6
Časové okno: Day 0 to 28

Change between AP-Brain and placebo between AP-Brain and placebo in markers of inflammation, as assessed by Creactive protein (CRP), tumor necrosis factor alpha (TNF-α), and interleukin (IL)-6
Day 0 to 28
Change between AP-Brain and placebo between AP-Brain and placebo in markers of inflammation, as assessed by C-reactive protein (CRP), tumor necrosis factor alpha (TNF-α), and interleukin (IL)-6
Časové okno: Day 0 to 56]

Change between AP-Brain and placebo between AP-Brain and placebo in markers of inflammation, as assessed by C-reactive protein (CRP), tumor necrosis factor alpha (TNF-α), and interleukin (IL)-6
Day 0 to 56]
Difference in product perception between AP-Brain and placebo at Day 56, as assessed by the Product Perception Questionnaire (PPQ).
Časové okno: Day 0 to 56

Difference in product perception between AP-Brain and placebo at Day 56, as assessed by the Product Perception Questionnaire (PPQ). Not scored on a scale, answers range from Strongly Agree to Strongly Disagree.
Day 0 to 56

Další výstupní opatření

Další výstupní opatření

U klinických studií plánované měření popsané v protokolu, které se používá ke stanovení účinku intervence/léčby na účastníky. U pozorovacích studií měření nebo pozorování, které se používá k popisu vzorců nemocí nebo rysů nebo souvislostí s expozicemi, rizikovými faktory nebo léčbou. Typy měření výsledku zahrnují primární měření výsledku a sekundární měření výsledku.
Měření výsledku
Popis opatření
Časové okno
Incidence of pre-emergent and post-emergent adverse events (AE)
Časové okno: Day 0 to 56

Incidence of pre-emergent and post-emergent adverse events (AE)
Day 0 to 56
Clinically relevant changes in vital signs (blood pressure (BP) after supplementation
Časové okno: Day 0 to 56

Clinically relevant changes in vital signs (blood pressure (BP) after supplementation
Day 0 to 56
Clinically relevant changes in heart rate (HR)) after supplementation
Časové okno: Day 0 to 56

Clinically relevant changes in heart rate (HR)) after supplementation
Day 0 to 56

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Sponzor

Organizace nebo osoba, která iniciuje studii a která má autoritu a kontrolu nad studií.
Rousselot BVBA

Spolupracovníci

Spolupracovníci

Organizace jiná než zadavatel, která poskytuje podporu klinické studii. Tato podpora může zahrnovat činnosti související s financováním, návrhem, implementací, analýzou dat nebo podáváním zpráv.
KGK Science Inc.

Vyšetřovatelé

Vyšetřovatelé

Výzkumník zapojený do klinické studie. Související pojmy zahrnují hlavní řešitel, dílčí řešitel, vedoucí studie, vedoucí studie a hlavní řešitel studie.
  • Vrchní vyšetřovatel: David Crowley, MD, KGK Science Inc.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

Začátek studia

Skutečné datum, kdy byl první účastník zařazen do klinické studie. „Očekávané“ datum zahájení studie je datum, o kterém si vědci myslí, že bude datem zahájení studie.
22. července 2026

Primární dokončení (Odhadovaný)

Primární dokončení

Datum, kdy byl poslední účastník klinické studie vyšetřen nebo obdržel intervenci ke sběru konečných dat pro primární měření výsledku. Zda byla klinická studie ukončena podle protokolu nebo byla ukončena, toto datum neovlivňuje. U klinických studií s více než jedním primárním výstupním měřením s různými daty dokončení se tento termín vztahuje k datu, kdy je dokončen sběr dat pro všechna primární výsledná měření. „Očekávané“ datum primárního dokončení je datum, o kterém si vědci myslí, že bude primárním datem dokončení studie.
1. srpna 2027

Dokončení studie (Odhadovaný)

Dokončení studie

Datum, kdy byl poslední účastník klinické studie vyšetřen nebo dostal intervenci/léčbu za účelem shromáždění konečných dat pro měření primárního výsledku, sekundárního měření výsledku a nežádoucí příhody (tj. poslední návštěva posledního účastníka). „Očekávané“ datum dokončení studie je datum, o kterém si vědci myslí, že bude datem dokončení studie.
1. srpna 2027

Termíny zápisu do studia

První předloženo

První předloženo

Datum, kdy zadavatel studie nebo zkoušející poprvé předložil záznam studie na ClinicalTrials.gov. Mezi prvním odeslaným datem a dostupností záznamu na ClinicalTrials.gov (první zveřejněné datum) je obvykle několik dní.
27. ledna 2026

První předloženo, které splnilo kritéria kontroly kvality

První předloženo, které splnilo kritéria kontroly kvality

Datum, kdy zadavatel studie nebo zkoušející poprvé předloží záznam studie, který je v souladu s kritérii kontroly kvality (QC) Národní lékařské knihovny (NLM). Sponzor nebo zkoušející může potřebovat revidovat a předložit záznam studie jednou nebo vícekrát, než budou splněna kritéria kontroly kontroly kvality NLM. Je odpovědností sponzora nebo zkoušejícího zajistit, aby byl záznam studie v souladu s kritérii kontroly kontroly kvality NLM.
27. ledna 2026

První zveřejněno (Aktuální)

První zveřejněno

Datum, kdy byl záznam studie poprvé k dispozici na webu ClinicalTrials.gov poté, co byla dokončena kontrola kontroly kvality (QC) National Library of Medicine (NLM). Mezi datem, kdy zadavatel studie nebo zkoušející předložil záznam studie, a prvním zveřejněným datem je typicky několik dní zpoždění.
5. února 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

Poslední zveřejněná aktualizace

Nejnovější datum, kdy byly změny záznamu studie zpřístupněny na ClinicalTrials.gov. Mezi okamžikem, kdy byly změny odeslány na ClinicalTrials.gov sponzorem nebo zkoušejícím studie (datum poslední předložení aktualizace), a datem zveřejnění poslední aktualizace může nastat zpoždění.
12. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

Nejnovější datum, kdy zadavatel studie nebo zkoušející předložil změny záznamu studie, které jsou v souladu s kritérii kontroly kvality (QC) National Library of Medicine (NLM). Je odpovědností sponzora nebo zkoušejícího zajistit, aby byl záznam studie v souladu s kritérii kontroly kontroly kvality NLM.
11. listopadu 2026

Naposledy ověřeno

Naposledy ověřeno

Nejnovější datum, kdy zadavatel studie nebo zkoušející potvrdil informace o klinické studii na webu ClinicalTrials.gov jako přesné a aktuální. Pokud jde o studii s náborovým statusem náboru; ještě nenabírá nábor; nebo aktivní, nebyl nábor potvrzen během posledních 2 let, status náboru studie je uveden jako neznámý.
1. listopadu 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

Další identifikační čísla studie

Identifikátory nebo ID čísla jiná než číslo NCT, které klinické studii přiděluje zadavatel studie, financující subjekty nebo jiní. Tato čísla mohou zahrnovat jedinečné identifikátory z jiných registrů studií a čísla grantů National Institutes of Health.
  • 25RBCCT03

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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