Home/Get Matched/NCT07388043
Recruiting
View on ClinicalTrials.gov

Testing AP-Brain (1g) against a placebo for cognition

Official title: 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

Condition: CognitionSponsor: Rousselot BVBATarget enrollment: 120
  • 4 groups
  • 2 sites in London
  • Recruiting
KGK Science Inc., London, OntarioKGK Science Inc., London, Ontario

Interventions (4)

  • Other intervention

    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.

  • Other intervention

    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.

  • Other intervention

    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.

Canadian Sites (2)

1 of 2 recruiting

  • KGK Science Inc.

    London, Ontario

    Recruiting
  • KGK Science Inc.

    London, Ontario

    Not yet recruiting

Eligibility Criteria

See who this study is looking for50 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Males and females 40-79 years of age, inclusive
  • +Agrees to avoid first generation anti-allergy medication for 48 hours prior to post-screeningScreeningThe checks done before joining, to see whether a study fits.Read more → clinic visits
  • +Individuals of child-bearing potential must have a negative baselineBaselineYour starting measurements, taken before treatment begins.Read more → urine pregnancy test and agree to use a medically approved method of birth controlControl groupThe group a new treatment is measured against.Read more → 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:
  • +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
  • +Double-barrier method
  • +Intrauterine devices
  • +Vasectomy of partner at least 6 months prior to screening
  • +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 moderate-vigorous exercise 12 hours prior to post-screening clinic visits
  • +Agrees to avoid travel across two or more time zones two weeks prior to any study visit
  • +Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
  • +Willing and able to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
  • +Provided voluntary, written, informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to participate in the study
  • +Healthy as determined by medical history, laboratory results, and vital signs, as assessed by the QI
  • +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)
  • +Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
  • +Abstinence and agrees to use contraception if planning on becoming sexually active

Exclusion

  • Allergy, sensitivity, or intolerance to the investigational product or placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → ingredients
  • Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
  • 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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → 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
  • Individuals with an autoimmune disease or are immune compromised as assessed by the QI
  • Self-reported confirmation of blood/bleeding disorders as assessed by QI
  • Use of medical cannabinoid products
  • Chronic use of cannabinoid products (\>2 times/week). Occasional users will be required to washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more → and abstain for the duration of the study period
  • Alcohol intake average of \>2 standard drinks per day as assessed by the QI
  • Alcohol or drug abuse within the last 12 months
  • 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)
  • Current or previous use of cognitive training programs or therapies, as assessed by the QI
  • Clinically significant abnormal laboratory results at screening as assessed by the QI
  • Blood donation 30 days prior to baselineBaselineYour starting measurements, taken before treatment begins.Read more →, during the study, or a planned donation within 30 days of the last study visit
  • Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
  • Individuals who are cognitively impaired and/or unable to give informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
  • 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
  • Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
  • 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
  • Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow upFollow-upContinued check-ins after the treatment part is finished.Read more → that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
  • 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
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 4 groups in this study.

Group A receives AP-Brain (1g).

Registry label: A: AP-Brain (1g)

Group B receives AP-Brain (3g).

Registry label: B: AP-Brain (3g)

Group C receives AP-Brain (5g).

Registry label: C: AP-Brain (5g)

Group D, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.

Registry label: D: Placebo

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists an age range of 40 years to 79 years.

The study is open to people of any sex.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 120 people.

The study is currently expected to finish around November 2026.

The main measurement is taken over: Day 0 to 56.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → to Day 56 between AP-Brain and placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → in cognitive performance, as assessed by the CNS VS Neurocognitive Index (NCI) score — measured over 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 — measured over Day 0 to 56.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07388043 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About 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.

From the trial registry — its own words, unedited.

What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.

Read the full explanation → · in clinical review

About 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.

From the trial registry — its own words, unedited.

What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.

Read the full explanation → · in clinical review

About 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.

From the trial registry — its own words, unedited.

What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.

Read the full explanation → · in clinical review

About PlaceboOther

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.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 40 years to 79 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 40 years to 79 years.

It is open to people of any sex.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Day 0 to 56.

The study as a whole is currently expected to finish around 2026-11.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 120 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: London, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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.

Think this trial might be right for you?

Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.

See if this trial could fit you

This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.