MCIBREAK-ADNCT04466735
BRain Energy Activation With Ketones to Prevent Alzheimer's Disease
A study testing Active group in people with MCI, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
A six month randomized controlled intervention with an exogenous ketone salt (EKS) supplement in mild cognitive impairment. Participants will receive 15 g of the supplement twice daily (equivalent to 24 g/day of EKS). Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- MCI
- What is being tested?
- Active group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2020to 10 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participant must answer Yes to the question ''Do you think your memory is not as good as it was?''
- Have a MoCA Score between 20/30 and 26/30
- Have a QAF score of less than 9/30
- Understand, read and talk French
- Having good visual and hearing acuity
Who cannot join
- Major cognitive decline or neurodegenerative disease.
- Already consuming a daily medium chain triglyceride or ketone supplement.
- Soy, milk, gluten or allergy to the study product
- Controlled or uncontrolled diabetes
- Uncontrolled chronic disease
- Vitamin B12 deficit
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- Clinical anomaly in the blood chemistry profile
- QSP-9 score over 19/27
- Taking an anti-cholinergic drugs
- Recent change in medication
- Active cancer in the last 2 years
- General anesthesia in the last 6 months
- history of alcohol abuse or dependence in the last 2 years
- Participation in other interventional or PET research project
- Unable to undergo an MRI or PET scan
- History of kidney stones or hypercalcemia
- History of cardiovascular events or insufficiency
- Renal failure and / or creatinine <58 umol or> 110 umol for men and <46 umol or> 92 umol for women or if the GFR (glomerular filtration rate) <60 ml / min / 1.73 m2
- Chronic disease of the digestive system or intestinal malabsorption (celiac disease, chronic pancreatitis, Crohn's disease, etc.)
- Body mass index <20 or voluntary weight loss of more than 5% in the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 6 Month Randomized Controlled Trial With D-beta-hydroxybutyrate in Mild Cognitive Impairment
A six month randomized controlled intervention with an exogenous ketone salt (EKS) supplement in mild cognitive impairment. Participants will receive 15 g of the supplement twice daily (equivalent to 24 g/day of EKS). Outcomes: brain energy metabolism, cognition, plasma biomarkers, brain imaging (volumetric, functional, structural) and quality of life will be analyzed before and after the intervention.
- Conditions
- MCI
- Being tested
- Active group, Placebo group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active groupDietary supplement
2 x 12 g of EKS/day
Placebo groupDietary supplement
Isocaloric placebo supplement with similar salt load but no EKS
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | Participants will be on the active intervention for 6 months Receives: Dietary Supplement: Active group |
| Placebo Group | Placebo comparator | Participants will be on the placebo intervention for 6 months Receives: Dietary Supplement: Placebo group |
| Open phase on active product | Active comparator | 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. Receives: Dietary Supplement: Active group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetoacetate brain uptake
CMRacac measured by PET Scan
Measured: 6 months
Glucose brain uptake
CMRgluc measured by PET Scan
Measured: 6 months
Secondary outcomes (3)
Cognition
Measured: 0-3-6-9 months
Plasma biomarkers
glucose, fatty acids, ketones
Measured: 9 months
Structural and functional brain measures
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start15 Oct 2020
- Primary completion12 Dec 2024
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MCIStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial. First phase :Two parallel groups, one placebo, one active Second phase : All participants will be invited to take part in an open phase on the active product only.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association, Nestle Health Science
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466735
- Sponsor's protocol ID
- 2020-3448
- Acronym
- BREAK-AD
- Status last verified
- May 2025
- First submitted
- 7 Jul 2020
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 6 Month Randomized Controlled Trial With D-beta-hydroxybutyrate in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04466735
- Acronym / sponsor ID
- BREAK-AD / 2020-3448
- Conditions
- MCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Alzheimer's Association, Nestle Health Science
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A six month randomized controlled intervention with an exogenous ketone salt (EKS) supplement in mild cognitive impairment. Participants will receive 15 g of the supplement twice daily (equivalent to 24 g/day of EKS). Outcomes: brain energy metabolism, cognition, plasma biomarkers, brain imaging (volumetric, functional, structural) and quality of life will be analyzed before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial. First phase :Two parallel groups, one placebo, one active Second phase : All participants will be invited to take part in an open phase on the active product only.
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Dietary Supplement: Active groupParticipants will be on the active intervention for 6 months |
| Placebo Group | Placebo comparator | Dietary Supplement: Placebo groupParticipants will be on the placebo intervention for 6 months |
| Open phase on active product | Active comparator | Dietary Supplement: Active groupAt 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The participant must answer Yes to the question ''Do you think your memory is not as good as it was?''
- Have a MoCA Score between 20/30 and 26/30
- Have a QAF score of less than 9/30
- Understand, read and talk French
- Having good visual and hearing acuity
Key exclusion criteria (20 listed)
- Major cognitive decline or neurodegenerative disease.
- Already consuming a daily medium chain triglyceride or ketone supplement.
- Soy, milk, gluten or allergy to the study product
- Controlled or uncontrolled diabetes
- Uncontrolled chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active group2 x 12 g of EKS/day | Dietary supplement | Active group, Open phase on active product |
| Placebo groupIsocaloric placebo supplement with similar salt load but no EKS | Dietary supplement | Placebo Group |
Primary outcome
Acetoacetate brain uptake
Time frame: 6 months
CMRacac measured by PET Scan
Glucose brain uptake
Time frame: 6 months
CMRgluc measured by PET Scan
3 secondary outcomes
Cognition
Time frame: 0-3-6-9 months
Plasma biomarkers
Time frame: 9 months
Structural and functional brain measures
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active group in people with MCI, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acetoacetate brain uptake (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.