BRain Energy Activation With Ketones to Prevent Alzheimer's Disease

NCT04466735 | Completed DMC

• 1 other identifier: 2020-3448
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (2)

• Acetoacetate brain uptake

  CMRacac measured by PET Scan

  6 months

• Glucose brain uptake

  CMRgluc measured by PET Scan

  6 months

Secondary Outcomes (3)

• Cognition

  0-3-6-9 months

• Plasma biomarkers

  9 months

• Structural and functional brain measures

  6 months

Study Arms (3)

Active group

EXPERIMENTAL

Participants will be on the active intervention for 6 months

Dietary Supplement: Active group

Placebo Group

PLACEBO COMPARATOR

Participants will be on the placebo intervention for 6 months

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.

Dietary Supplement: Active group

Interventions

Active group DIETARY_SUPPLEMENT

2 x 12 g of EKS/day

Active group; Open phase on active product

Placebo group DIETARY_SUPPLEMENT

Isocaloric placebo supplement with similar salt load but no EKS

Placebo Group

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Alzheimer's Association: collaborator
• Nestle Health Science: collaborator

Study Sites (1)

Rearsh Centre on Aging

Sherbrooke, Quebec, J1H4C4, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators, participants and outcome assessors will be fully blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: October 15, 2020
• Primary Completion: December 12, 2024
• Study Completion: March 10, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

CA (1)