AP-Brain for Cognitive Functioning

MM
Overseen ByMarc Moulin, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new supplement, AP-Brain, to determine if it can improve attention and memory in healthy younger adults who often have trouble focusing. Participants will take varying doses of AP-Brain or a placebo to compare effects on cognitive function over about two months. The study seeks individuals aged 18-39 who frequently struggle with attention and can maintain a stable lifestyle throughout the trial. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on cognitive enhancement.

Will I have to stop taking my current medications?

The trial requires participants to maintain their current lifestyle habits, including medications, as much as possible throughout the study. However, if you are taking medications that might impact the study's safety or efficacy, you may need to stop or adjust them. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that hydrolyzed collagen, such as that used in AP-Brain, is generally safe and well-tolerated. A study on a similar product, CollaSel Pro®, found it safe for improving skin health, with no serious side effects reported. Research suggests that collagen peptides can positively impact brain structure and improve language skills, indicating safety for brain use. Although collagen supplements are not recommended during pregnancy or breastfeeding due to limited data, they have not shown major safety issues in other adults.12345

Why are researchers excited about this trial?

Unlike other treatments for cognitive functioning, which often focus on enhancing neurotransmitter activity or blood flow to the brain, AP-Brain is derived from hydrolyzed collagen. This makes it unique because it introduces a new active ingredient not typically used in this field. Researchers are excited about AP-Brain because it explores the potential benefits of collagen on brain health, offering a novel approach with different dosages: 1g, 3g, and 5g. This could pave the way for alternative or complementary options to existing cognitive enhancers.

What evidence suggests that AP-Brain could be an effective treatment for attention problems?

Research has shown that collagen supplements might improve brain health and thinking skills. Some studies found that daily collagen intake can alter the brain and enhance language skills. These findings suggest potential brain benefits from collagen. However, the benefits appear stronger with higher doses, around 10 to 20 grams, taken over an extended period. In this trial, participants will receive different dosages of AP-Brain—specifically 1g, 3g, or 5g—or a placebo. Although this trial uses different dosages, the potential for cognitive improvements remains promising.26789

Who Is on the Research Team?

DC

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

This trial is for healthy younger adults who feel they have attention issues. Participants will be asked to take a substance called AP-Brain at different doses or a placebo and complete memory tests.

Inclusion Criteria

Individuals with self-reported focus or attention problems
Willing and able to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
Agrees to avoid high sources of caffeine, NSAIDs, and alcohol consumption for 24 hours prior to post-screening clinic visits
See 9 more

Exclusion Criteria

Chronic use of cannabinoid products
Allergy, sensitivity, or intolerance to the investigational product or placebo ingredients
I have been diagnosed or treated for ADHD.
See 28 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AP-Brain at varying dosages (1g, 3g, or 5g) or placebo and complete memory assessment questionnaires

8 weeks
Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AP-Brain

Trial Overview

The study is testing the safety and effectiveness of varying doses of AP-Brain (1g, 3g, or 5g) compared to a placebo in improving cognitive function over 56 days in participants with self-reported attention problems.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: AP-Brain (5g)Experimental Treatment1 Intervention
Group II: AP-Brain (3g)Experimental Treatment1 Intervention
Group III: AP-Brain (1g)Experimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rousselot BVBA

Lead Sponsor

Trials
8
Recruited
220+

KGK Science Inc.

Industry Sponsor

Trials
82
Recruited
6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution

Citations

Effects of Collagen Hydrolysates on Human Brain Structure ...

It is possible that the ingestion of CH may change brain structure and improve cognitive function, potentially helping patients to recover from brain damage. In ...

(PDF) Effects of Collagen Hydrolysates on Human Brain ...

This study investigated the effects of collagen hydrolysates (CH) on language cognitive function and brain structure.

Collagen peptides supplementation improves function ...

These findings suggest 10 to 20 g/d of CP supplementation over 6 to 9 months may improve ADLs, pain, MCS, and PCS in middle-aged active adults.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31878021/

Effects of Collagen Hydrolysates on Human Brain Structure ...

Daily ingestion of CH changed brain structure and improved language cognitive function. Keywords: cognitive health; collagen hydrolysate ...

Collagen supplementation for sleep among physically ...

In this randomized controlled trial in physically active men, supplementation with collagen did not reduce sleep latency or improve sleep efficiency.

A Clinical Trial to Investigate the Safety and Efficacy of AP ...

The goal of this clinical trial is to investigate the safety and efficacy of AP-Brain on cognitive function at varying dosages in healthy ...

The Efficacy and Safety of CollaSel Pro® Hydrolyzed ...

Accordingly, CollaSel Pro® hydrolyzed collagen peptide can be considered a well-tolerated, safe product that effectively improves dermal health ...

Do Collagen Supplements Work? Science-Backed Benefits ...

Not recommended in pregnancy or breastfeeding due to insufficient safety data9. Limitations and controversies. Collagen supplements vary ...

Ingestion of a collagen peptide containing high concentrations ...

Furthermore, they have been confirmed to cause changes in the brain's structure and improve language cognitive function (Koizumi et al.2020).