BREAK-AD: BRain Energy Activation With Ketones to Prevent Alzheimer's Disease

Sponsor

Université de Sherbrooke (Other)

Overall Status

Recruiting

CT.gov ID

NCT04466735

Collaborator

Alzheimer's Association (Other), Nestlé Health Science SA (Other)

Enrollment

Location

Arms

32.5

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
MCI	Dietary Supplement: Active group Dietary Supplement: Placebo group	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Investigator, Outcomes Assessor)

Masking Description:

Investigators, participants and outcome assessors will be fully blinded.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 15, 2020

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active group Participants will be on the active intervention for 6 months	Dietary Supplement: Active group 2 x 12 g of EKS/day
Placebo Comparator: Placebo Group Participants will be on the placebo intervention for 6 months	Dietary Supplement: Placebo group Isocaloric placebo supplement with similar salt load but no EKS
Active Comparator: Open phase on active product 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 2 x 12 g of EKS/day

Arm

Intervention/Treatment

Experimental: Active group

Participants will be on the active intervention for 6 months

Dietary Supplement: Active group

2 x 12 g of EKS/day

Placebo Comparator: Placebo Group

Participants will be on the placebo intervention for 6 months

Dietary Supplement: Placebo group

Isocaloric placebo supplement with similar salt load but no EKS

Active Comparator: Open phase on active product

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

2 x 12 g of EKS/day

Outcome Measures

Primary Outcome Measures

Acetoacetate brain uptake [6 months]
CMRacac measured by PET Scan
Glucose brain uptake [6 months]
CMRgluc measured by PET Scan

Secondary Outcome Measures

Cognition [0-3-6-9 months]
Plasma biomarkers [9 months]
glucose, fatty acids, ketones
Structural and functional brain measures [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 25/30
Have a Wechsler memory scale III score on 25 of:
11 for 16 years of education,
9 for 8-15 years of education,
6 for 0-7 years of education.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rearsh Centre on Aging	Sherbrooke	Quebec	Canada	J1H4C4

Sponsors and Collaborators

Université de Sherbrooke
Alzheimer's Association
Nestlé Health Science SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Université de Sherbrooke

ClinicalTrials.gov Identifier:

NCT04466735

Other Study ID Numbers:

2020-3448

First Posted:

Jul 10, 2020

Last Update Posted:

Nov 3, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 3, 2020