Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Un essai clinique visant à étudier la sécurité et l'efficacité d'AP-Brain sur la fonction cognitive à différentes posologies chez des jeunes adultes en bonne santé présentant des problèmes d'attention auto-déclarés

16 septembre 2026 mis à jour par: Rousselot BVBA

Un essai clinique randomisé, triple insu, contrôlé par placebo, en parallèle, de preuve de concept pour étudier la sécurité et l'efficacité d'AP-Brain sur la fonction cognitive à différentes doses chez des jeunes adultes en bonne santé présentant des problèmes d'attention auto-déclarés

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

120

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Canada
    • Ontario
      • London, Ontario, Canada, N6B3L1
        • Recrutement
        • KGK Science Inc.
        • Contact:
      • London, Ontario, Canada, N6B3L1
        • Pas encore de recrutement
        • KGK Science Inc.
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 39 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: AP-Brain (1g)

AP-Brain (1g) contains 1 g of hydrolyzed collagen in a capsule
Complément alimentaire: 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.
Expérimental: AP-Brain (3g)

AP-Brain (3 g) contains 3 g of hydrolyzed collagen in a capsule
Complément alimentaire: 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
Expérimental: AP-Brain (5g)

AP-Brain (5 g) contains 5 g of hydrolyzed collagen in a capsule
Complément alimentaire: 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
Comparateur placebo: Placebo

Placebo consists of Silicified Microcrystalline Cellulose, magnesium stearate, Hydroxypropyl cellulose, and titanium dioxide
Complément alimentaire: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from baseline to Day 56 between AP-Brain and placebo in cognitive function, as assessed by the CNS VS Neurocognitive Index (NCI) score
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 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.
Délai: 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
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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)
Délai: 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
Délai: 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
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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
Délai: 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.
Délai: 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)
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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)
Délai: 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
Délai: 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
Délai: 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).
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Incidence of pre-emergent and post-emergent adverse events (AE)
Délai: 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
Délai: 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
Délai: Day 0 to 56

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Rousselot BVBA

Collaborateurs

KGK Science Inc.

Les enquêteurs

  • Chercheur principal: David Crowley, MD, KGK Science Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 juillet 2026

Achèvement primaire (Estimé)

1 novembre 2026

Achèvement de l'étude (Estimé)

1 novembre 2026

Dates d'inscription aux études

Première soumission

27 janvier 2026

Première soumission répondant aux critères de contrôle qualité

27 janvier 2026

Première publication (Réel)

5 février 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 25RBCCT03

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner