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OpenTrials
Completed

NCT Number: NCT04466735

BRain Energy Activation With Ketones to Prevent Alzheimer's Disease

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.

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Key information

Conditions

MCI

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rearsh Centre on Aging

Sherbrooke, Quebec, J1H4C4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Active group

Dietary Supplement

2 x 12 g of EKS/day

Placebo Group

Dietary Supplement

Isocaloric placebo supplement with similar salt load but no EKS

Primary outcomes

  1. Acetoacetate brain uptake

    Time frame: 6 months

    CMRacac measured by PET Scan

  2. Glucose brain uptake

    Time frame: 6 months

    CMRgluc measured by PET Scan

Secondary outcomes

  1. Cognition

    Time frame: 0-3-6-9 months

  2. Plasma biomarkers

    Time frame: 9 months

    glucose, fatty acids, ketones

  3. Structural and functional brain measures

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Alzheimer's Association
  • Nestle Health Science

Registry information

Official study title

6 Month Randomized Controlled Trial With D-beta-hydroxybutyrate in Mild Cognitive Impairment

Acronym: BREAK-AD

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jul 10, 2020
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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