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一项研究不同剂量AP-Brain对自述存在记忆问题的健康中老年人认知功能安全性与有效性的临床试验

2026年9月16日 更新者：Rousselot BVBA

一项随机、三盲、安慰剂对照、平行、概念验证临床试验，旨在研究AP-Brain在不同剂量下对自述存在记忆问题的健康中老年人认知功能的安全性和有效性

The goal of this clinical trial is to investigate the safety and efficacy of AP-Brain on cognitive performance at varying dosages in healthy middle-aged and older adults with self-reported memory problems. The main question it aims to answer is:

What is the effect of AP-Brain at 1 g, 3 g, and 5 g on cognitive performance?

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

研究概览

地位

地位

指示当前招聘状态或扩展访问状态。
招聘中

条件

条件

正在研究的疾病、紊乱、综合征、疾病或损伤。在 ClinicalTrials.gov 上，条件还可能包括其他与健康相关的问题，例如寿命、生活质量和健康风险。

干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。

研究类型

研究类型

描述临床研究的性质。研究类型包括介入性研究（也称为临床试验）、观察性研究（包括患者登记）和扩展访问。
介入性

注册 (估计的)

注册

临床研究的参与者人数。 “预期”入组人数是研究人员进行研究所需的目标参与者人数。
120

阶段

阶段

根据美国食品和药物管理局 (FDA) 制定的定义，研究药物或生物制品的临床试验阶段。阶段基于研究的目标、参与者的数量和其他特征。有五个阶段：早期第 1 阶段（以前列为第 0 阶段）、第 1 阶段、第 2 阶段、第 3 阶段和第 4 阶段。不适用用于描述没有 FDA 定义的阶段的试验，包括设备试验或行为干预。
  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习联系方式

可以回答临床研究注册问题的人员的姓名和联系信息。进行研究的每个地点也可能有特定的联系人，他们可能能够更好地回答这些问题。

学习地点

  • 加拿大
    • Ontario
      • London、Ontario、加拿大、N6B3L1
        • 招聘中
        • KGK Science Inc.
        • 接触：
      • London、Ontario、加拿大、N6B3L1
        • 尚未招聘
        • KGK Science Inc.
        • 首席研究员：
          • David Crowley, MD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

资格标准

想要参加临床研究的人必须满足的关键要求或他们必须具备的特征。资格标准包括纳入标准（一个人参与研究所必需的）和排除标准（阻止一个人参与）。资格标准的类型包括一项研究是否接受健康志愿者、是否有年龄或年龄组要求，或是否受性别限制。

适合学习的年龄

40年 至 79年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Males and females 40-79 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 memory problems as assessed by a combined score of ≥6 from the memory assessment questions provided at screening

  4. Absence of dementia or other significant cognitive impairment as assessed by MMSE-2 score of ≥24 at screening

  5. 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

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

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

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

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

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

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

  12. 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. Self-reported confirmation of any significant neuropsychological condition and/or cognitive impairment (e.g., attention-deficit/hyperactivity 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
  4. Self-reported color blindness/weakness as assessed by the QI
  5. Individuals who consume high caffeine daily or are addicted to caffeine at screening as assessed by the QI
  6. Current employment that calls for overnight shiftwork as assessed by the QI
  7. Unstable metabolic disease or chronic diseases as assessed by the QI
  8. Current or history of significant diseases of the gastrointestinal tract or conditions that result in malabsorption, as assessed by the QI
  9. 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)
  10. Type I diabetes
  11. 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
  12. 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
  13. 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
  14. 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
  15. 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
  16. 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
  17. Individuals with an autoimmune disease or are immune compromised as assessed by the QI
  18. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
  19. Self-reported confirmation of blood/bleeding disorders as assessed by QI
  20. Use of medical cannabinoid products
  21. Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
  22. 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
  23. Alcohol intake average of >2 standard drinks per day as assessed by the QI
  24. Alcohol or drug abuse within the last 12 months
  25. 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)
  26. Current or previous use of cognitive training programs or therapies, as assessed by the QI
  27. Clinically significant abnormal laboratory results at screening as assessed by the QI
  28. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
  29. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
  30. Individuals who are cognitively impaired and/or unable to give informed consent
  31. 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂

参与者组/臂

根据试验方案，接受特定干预/治疗或不接受干预的临床试验参与者组或亚组。
干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。
实验性的：AP-Brain (1g)

AP-Brain (1g) contains 1 g of hydrolyzed collagen in a capsule
膳食补充剂：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 AP-Brain capsule and 4 placebo capsules.
实验性的：AP-Brain (3g)

AP-Brain (3 g) contains 3 g of hydrolyzed collagen in a capsule
膳食补充剂：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 AP-Brain capsules and 2 placebo capsules.
实验性的：AP-Brain (5g)

AP-Brain (5 g) contains 5 g of hydrolyzed collagen in a capsule
膳食补充剂：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 AP-Brain capsules and 0 placebo capsules.
安慰剂比较：Placebo

Placebo consists of Silicified Microcrystalline Cellulose, magnesium stearate, Hydroxypropyl cellulose, and titanium dioxide
其他：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 5 0 AP-Brain capsules and 5 placebo capsules.

研究衡量的是什么？

主要结果指标

主要结果指标

在临床研究的方案中，对于评估干预/治疗的效果最重要的计划结果测量。大多数临床研究有一项主要结果指标，但有些研究有不止一项。
结果测量
措施说明
大体时间
Change from baseline to Day 56 between AP-Brain and placebo in cognitive performance, as assessed by the CNS VS Neurocognitive Index (NCI) score
大体时间：Day 0 to 56

Change from baseline to Day 56 between AP-Brain and placebo in cognitive performance, 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 domains.
Day 0 to 56
Change from baseline to Day 56 between AP-Brain and placebo in cognitive performance, as assessed by complex attention via the CNS VS battery test
大体时间：Day 0 to 56

Change from baseline to Day 56 between AP-Brain and placebo in cognitive performance, 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

次要结果测量

次要结果测量

在临床研究的方案中，计划的结果测量值在评估干预效果时不如主要结果测量值重要，但仍然值得关注。大多数临床研究有不止一项次要结果指标。
结果测量
措施说明
大体时间
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.
大体时间：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.
大体时间：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
大体时间：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 56 between AP-Brain and placebo in Complex attention via CNS VS test battery
大体时间：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 1 between AP-Brain and placebo in Verbal, visual, composite, and working memory assessed via CNS VS test battery.
大体时间：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 Verbal, visual, composite, and working memory assessed via CNS VS test battery.
大体时间：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.
大体时间：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 Processing, motor, and psychomotor speed assessed via CNS VS test battery.
大体时间：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.
大体时间：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: Reaction time assessed via CNS VS test battery.
大体时间：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.
大体时间：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 56 between AP-Brain and placebo in the following CNS VS measures: Simple and sustained attention assessed via CNS VS test battery.
大体时间：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 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: Executive function assessed via CNS VS test battery.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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 from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: Impulsivity assessed via CNS VS test battery.
大体时间：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 assessed via CNS VS test battery.
大体时间：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)
大体时间：Day 0 and 28

Change from baseline to Day 28 between AP-Brain and placebo in brain-derived neurotrophic factor (BDNF), as assessed via blood.
Day 0 and 28
Change in cognitive performance 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.
大体时间：Day 0 and 28

Change in cognitive performance 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 performance between AP-Brain and placebo based on change from baseline to Day 28 in Verbal, visual, composite, and working memory assessed via CNS VS test battery.
大体时间：Day 0 and 28

Change in cognitive performance 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 and 28
Change in cognitive performance 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.
大体时间：Day 0 and 56

Change in cognitive performance 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 and 56
Change in cognitive performance 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.
大体时间：Day 0 and 28

Change in cognitive performance 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 and 28
Change in cognitive performance 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.
大体时间：Day 0 and 56

Change in cognitive performance 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 performance 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.
大体时间：Day 0 and 28

Change in cognitive performance 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 performance 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.
大体时间：Day 0 and 56

Change in cognitive performance 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 56
Change in cognitive performance 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.
大体时间：Day 0 and 28

Change in cognitive performance 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 performance 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.
大体时间：Day 0 and 56

Change in cognitive performance 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 performance 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.
大体时间：Day 0 and 28

Change in cognitive performance 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 performance 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.
大体时间：Day 0 and 56

Change in cognitive performance 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 performance 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.
大体时间：Day 0 and 28

Change in cognitive performance 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 performance 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.
大体时间：Day 0 and 56

Change in cognitive performance 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 performance 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.
大体时间：Day 0 and 28

Change in cognitive performance 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 performance 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.
大体时间：Day 0 and 56

Change in cognitive performance 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)
大体时间：Day 0 and 28

Change between AP-Brain and placebo in insulin-like growth factor 1 (IGF-1) assessed via blood analysis
Day 0 and 28
Change between AP-Brain and placebo in insulin-like growth factor 1 (IGF-1)
大体时间：Day 0 to 56

Change between AP-Brain and placebo in insulin-like growth factor 1 (IGF-1)
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
大体时间：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
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
大体时间：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)
大体时间：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

其他结果措施

其他结果措施

对于临床试验，协议中描述的计划测量用于确定干预/治疗对参与者的影响。对于观察性研究，用于描述疾病或特征模式或与暴露、风险因素或治疗的关联的测量或观察。结果测量的类型包括主要结果测量和次要结果测量。
结果测量
措施说明
大体时间
Incidence of pre-emergent and post-emergent adverse events (AE)
大体时间：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
大体时间：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
大体时间：Day 0 to 56

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

赞助

发起研究并有权和控制研究的组织或个人。
Rousselot BVBA

合作者

合作者

为临床研究提供支持的赞助商以外的组织。这种支持可能包括与资金、设计、实施、数据分析或报告相关的活动。
KGK Science Inc.

调查人员

调查人员

参与临床研究的研究人员。相关术语包括中心首席研究员、中心副研究员、研究主席、研究主管和研究首席研究员。
  • 首席研究员：David Crowley、KGK Science Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

学习开始

第一位参与者参加临床研究的实际日期。 “预期”研究开始日期是研究人员认为将成为研究开始日期的日期。
2026年7月15日

初级完成 (估计的)

初级完成

临床研究的最后一名参与者接受检查或接受干预以收集主要结果测量的最终数据的日期。临床研究是否根据方案结束或被终止不影响该日期。对于具有多个不同完成日期的主要结果测量的临床研究，该术语是指完成所有主要结果测量的数据收集的日期。 “预期”主要完成日期是研究人员认为将成为研究主要完成日期的日期。
2026年11月1日

研究完成 (估计的)

研究完成

临床研究中最后一位参与者接受检查或接受干预/治疗以收集主要结局指标、次要结局指标和不良事件（即最后一位参与者的最后一次就诊）的最终数据的日期。 “预期”研究完成日期是研究人员认为将成为研究完成日期的日期。
2026年11月1日

研究注册日期

首次提交

首次提交

研究发起人或研究者首次向 ClinicalTrials.gov 提交研究记录的日期。在首次提交日期和记录在 ClinicalTrials.gov 上的可用性（首次发布日期）之间通常会有几天的延迟。
2026年1月14日

首先提交符合 QC 标准的

首先提交符合 QC 标准的

研究发起人或研究者首次提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录的日期。在满足 NLM 的 QC 审查标准之前，发起人或研究者可能需要修改和提交研究记录一次或多次。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年1月27日

首次发布 (实际的)

首次发布

在国家医学图书馆 (NLM) 质量控制 (QC) 审查结束后，研究记录首次在 ClinicalTrials.gov 上可用的日期。研究发起人或研究者提交研究记录的日期与首次发布日期之间通常会有几天的延迟。
2026年2月4日

研究记录更新

最后更新发布 (实际的)

最后更新发布

在 ClinicalTrials.gov 上提供研究记录更改的最近日期。研究发起人或研究者向 ClinicalTrials.gov 提交变更的时间（最后更新提交日期）和最后更新发布日期之间可能会有延迟。
2026年9月18日

上次提交的符合 QC 标准的更新

上次提交的符合 QC 标准的更新

研究发起人或研究者提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录更改的最近日期。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年9月16日

最后验证

最后验证

研究发起人或研究者确认 ClinicalTrials.gov 上的临床研究信息准确且最新的最近日期。如果一项研究的招募状态为招募；尚未招聘；或活跃，未在过去 2 年内确认招募，该研究的招募状态显示为未知。
2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

其他研究编号

由研究的发起人、资助者或其他人分配给临床研究的标识符或 ID 号，而不是 NCT 号。这些编号可能包括来自其他试验登记处的唯一标识符和美国国立卫生研究院的资助编号。
  • 25RBCCT02

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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