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Ketone Supplement

Ketone Supplement for Mild Cognitive Impairment (BREAK-AD Trial)

Phase 2
Recruiting
Research Sponsored by Université de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Understand, read and talk French
The participant must answer Yes to the question 'Do you think your memory is not as good as it was?'
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-3-6-9 months
Awards & highlights

BREAK-AD Trial Summary

This trial will study the effects of a ketone supplement on brain function and metabolism in people with mild cognitive impairment.

Who is the study for?
This trial is for individuals with mild cognitive impairment who can understand, read, and speak French, have good vision and hearing, feel their memory has declined, and score within a specific range on cognitive tests. Excluded are those with certain medical conditions like kidney failure or recent cancer, vitamin deficiencies, drastic weight loss recently, or taking conflicting medications.Check my eligibility
What is being tested?
The study is testing an exogenous ketone salt supplement given twice daily over six months against a placebo to see if it improves brain energy metabolism, cognition and quality of life in people with mild cognitive impairment. Brain imaging and plasma biomarkers will also be assessed.See study design
What are the potential side effects?
While the side effects aren't specified here for the ketone supplement being tested in this trial; similar supplements sometimes cause digestive discomforts such as nausea or stomach pain. Allergies could occur due to ingredients like soy or milk.

BREAK-AD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can understand, read, and speak French.
Select...
I believe my memory is not as good as it used to be.

BREAK-AD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-3-6-9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-3-6-9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acetoacetate brain uptake
Glucose brain uptake
Secondary outcome measures
Cognition
Plasma biomarkers
Structural and functional brain measures

BREAK-AD Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Active groupExperimental Treatment1 Intervention
Participants will be on the active intervention for 6 months
Group II: Open phase on active productActive Control1 Intervention
At the end of the 6-month randomized controlled phase, participants will be unblinded and invited to continue on the active product for an additional 3 months.
Group III: Placebo GroupPlacebo Group1 Intervention
Participants will be on the placebo intervention for 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active group
2018
N/A
~140

Find a Location

Who is running the clinical trial?

Nestlé Health Science SAUNKNOWN
Alzheimer's AssociationOTHER
89 Previous Clinical Trials
40,707 Total Patients Enrolled
Nestle Health ScienceIndustry Sponsor
10 Previous Clinical Trials
2,004 Total Patients Enrolled

Media Library

Exogenous Ketone Salt (EKS) Supplement (Ketone Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04466735 — Phase 2
Mild Cognitive Impairment Research Study Groups: Open phase on active product, Active group, Placebo Group
Mild Cognitive Impairment Clinical Trial 2023: Exogenous Ketone Salt (EKS) Supplement Highlights & Side Effects. Trial Name: NCT04466735 — Phase 2
Exogenous Ketone Salt (EKS) Supplement (Ketone Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04466735 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrollment opportunities for this medical experiment?

"Affirmative. Clinicaltrials.gov reports that recruitment for this scientific inquiry, which went live on October 15th 2020, is open at the moment. 56 individuals are required from a single location to participate in these trials."

Answered by AI

Are participants under the age of 45 being considered for inclusion in this trial?

"As per the enrollment requirements, participants must be between 55 and 80 years of age."

Answered by AI

How many individuals are eligible to partake in this trial?

"Affirmative. The clinicaltrials.gov page for this trial reveals that recruitment is still open, with the first post published on October 15th 2020 and a subsequent update taking place November 2nd 2020. 56 participants are required at one location to complete the study."

Answered by AI

What criteria must a participant meet to be eligible for this trial?

"This clinical trial requires 56 participants aged between 55 and 80 who have been diagnosed with Mild cognitive impairment. Additionally, enrollees must provide a positive response to the question ''Do you think your memory is not as good as it was?'', possess a MoCA Score ranging from 20/30 to 25/30, receive 11 points for 16 years of education, 9 points for 8-15 years of education or 6 points 0-7 years of education., hold a QAF Score lower than 9/30, understand French in terms of reading comprehension and verbal communication abilities,,and demonstrate satisfactory visual acuity and hearing capacity."

Answered by AI

What adverse effects have been reported to ensue from Active group treatments?

"The safety of the Active Group was assessed as a 2 out of 3 due to its Phase 2 status, which indicates that there are limited data supporting efficacy but some evidence suggesting safety."

Answered by AI
~13 spots leftby Mar 2025