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临床试验/NCT07388043
NCT07388043
尚未招募
不适用

A Randomized, Triple-blind, Placebo-controlled, Parallel, Proof of Concept Clinical Trial to Investigate the Safety and Efficacy of AP-Brain on Cognitive Function at Varying Dosages in Healthy Middle-aged and Older Adults With Self-reported Memory Problems

Rousselot BVBA1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年5月1日最近更新:
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干预措施AP-Brain (1g)AP-Brain (3g)AP-Brain (5g)Placebo

概览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
Change from baseline to Day 56 between AP-Brain and placebo in cognitive function, as assessed by the CNS VS Neurocognitive Index (NCI) score
概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

概览

简要总结

The goal of this clinical trial is to safety and efficacy of AP-Brain on cognitive function 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 function?

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 79 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Males and females 40-79 years of age, inclusive
  • •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
  • •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
  • •Individuals with self-reported memory problems as assessed by a combined score of ≥6 from the memory assessment questions provided at screening

排除标准

  • •Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
  • •Allergy, sensitivity, or intolerance to the investigational product or placebo ingredients
  • •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
  • •Self-reported color blindness/weakness as assessed by the QI
  • •Individuals who consume high caffeine daily or are addicted to caffeine at screening as assessed by the QI
  • •Current employment that calls for overnight shiftwork as assessed by the QI
  • •Unstable metabolic disease or chronic diseases as assessed by the QI
  • •Current or history of significant diseases of the gastrointestinal tract or conditions that result in malabsorption, as assessed by the QI
  • •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)
  • •Type I diabetes

研究组 & 干预措施

AP-Brain (1g)

Experimental

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

干预措施: AP-Brain (1g) (Dietary Supplement)

AP-Brain (3g)

Experimental

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

干预措施: AP-Brain (3g) (Dietary Supplement)

AP-Brain (5g)

Experimental

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

干预措施: AP-Brain (5g) (Dietary Supplement)

Placebo

Placebo Comparator

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

干预措施: Placebo (Other)

结局指标

主要结局

Change from baseline to Day 56 between AP-Brain and placebo in cognitive function, as assessed by the CNS VS Neurocognitive Index (NCI) score

时间窗: 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 domains.

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

时间窗: 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.

次要结局

  • 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.(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.(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(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(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.(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.(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.(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.(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.(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.(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.(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.(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.(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.(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.(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.(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.(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.(Day 0 and 56)
  • 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.(Day 0 and 28)
  • Change in cognitive function 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.(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: Verbal, visual, composite, and working memory assessed via CNS VS test battery.(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: Processing, motor, and psychomotor speed assessed via CNS VS test battery.(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: Processing, motor, and psychomotor speed assessed via CNS VS test battery.(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.(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.(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: Simple and sustained attention assessed via CNS VS test battery.(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.(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.(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.(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.(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.(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.(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.(Day 0 and 56)
  • Change between AP-Brain and placebo in insulin-like growth factor 1 (IGF-1)(Day 0 and 28)
  • 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(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 56)
  • Difference in product perception between AP-Brain and placebo at Day 56, as assessed by the Product Perception Questionnaire (PPQ)(Day 0 to 56)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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