NCT04466735Completed
BRain Energy Activation With Ketones to Prevent Alzheimer's Disease
6 Month Randomized Controlled Trial With D-beta-hydroxybutyrate in Mild Cognitive Impairment
Source: ClinicalTrials.gov · Last updated 3 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 65 (actual)
- First submitted
- 7 Jul 2020
- Start date
- 15 Oct 2020
- Primary completion date
- 12 Dec 2024
- Lead sponsor
- Université de Sherbrooke
- Diseases
- Alzheimer disease
- NCT number
- NCT04466735
What you commit to
- Study type: Interventional
- Participants enrolled: 65
- From 15 Oct 2020 to the primary completion date, 12 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking an anti-cholinergic drugs
- Recent change in medication
Other illness
- Major cognitive decline or neurodegenerative disease.
- Soy, milk, gluten or allergy to the study product
- Controlled or uncontrolled diabetes
- Uncontrolled chronic disease
- Active cancer in the last 2 years
- history of alcohol abuse or dependence in the last 2 years
- History of kidney stones or hypercalcemia
- History of cardiovascular events or insufficiency
- Chronic disease of the digestive system or intestinal malabsorption (celiac disease, chronic pancreatitis, Crohn's disease, etc.)
Lab values
- 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
Other
- Already consuming a daily medium chain triglyceride or ketone supplement.
- Vitamin B12 deficit
- Clinical anomaly in the blood chemistry profile
- QSP-9 score over 19/27
- General anesthesia in the last 6 months
- Participation in other interventional or PET research project
- Unable to undergo an MRI or PET scan
- Body mass index \<20 or voluntary weight loss of more than 5% in the last 6 months.
Who the study is looking for
- 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
Age in the registry: 55 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rearsh Centre on Aging Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.