A Clinical Trial 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

A Randomized, Triple-blind, Placebo-controlled, Parallel, Proof of Concept Clinical Trial 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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07388043

Enrollment

120

Registered

2026-02-04

Start date

2026-06-01

Completion date

2026-11-01

Last updated

2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition, Cognitive Performance

Keywords

Memory, AP-Brain, cognitive performance

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTAP-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.

DIETARY_SUPPLEMENTAP-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.

DIETARY_SUPPLEMENTAP-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.

OTHERPlacebo

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 79 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline to Day 56 between AP-Brain and placebo in cognitive performance, as assessed by the CNS VS Neurocognitive Index (NCI) score	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.
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	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.

Secondary

Countries

Canada

Contacts

CONTACTMarc Moulin

mmoulin@kgkscience.com2267819094

PRINCIPAL_INVESTIGATORDavid Crowley

KGK Science Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026