A 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

NCT07388043 | Not Yet Recruiting

• 1 other identifier: 25RBCCT02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognition; Cognitive Function

Keywords

Memory; cognitive function; AP-Brain

Outcome Measures

Primary Outcomes (2)

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

  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.

  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

  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

Secondary Outcomes (39)

• 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

Other Outcomes (3)

• 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

  Day 0 to 56

• Clinically relevant changes in heart rate (HR)) after supplementation

  Day 0 to 56

Study Arms (4)

AP-Brain (1g)

EXPERIMENTAL

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

Dietary Supplement: AP-Brain (1g)

AP-Brain (3g)

EXPERIMENTAL

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

Dietary Supplement: AP-Brain (3g)

AP-Brain (5g)

EXPERIMENTAL

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

Dietary Supplement: AP-Brain (5g)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

AP-Brain (3g) DIETARY_SUPPLEMENT

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.

AP-Brain (3g)

AP-Brain (5g) DIETARY_SUPPLEMENT

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.

AP-Brain (5g)

Placebo OTHER

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.

Placebo

AP-Brain (1g) DIETARY_SUPPLEMENT

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.

AP-Brain (1g)

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Individuals with self-reported memory problems as assessed by a combined score of ≥6 from the memory assessment questions provided at screening
• Absence of dementia or other significant cognitive impairment as assessed by MMSE-2 score of ≥24 at screening
• 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
• Agrees to avoid first generation anti-allergy medication for 48 hours prior to post-screening clinic visits
• Agrees to avoid moderate-vigorous exercise 12 hours prior to post-screening clinic visits

You may not qualify if:

• 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
• 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
• 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
• 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
• 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
• 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

Sponsors & Collaborators

• KGK Science Inc.: collaborator
• Rousselot BVBA: lead

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B3L1, Canada

Location

Study Officials

• David Crowley

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Moulin

CONTACT

2267819094; mmoulin@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

CA (1)