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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04466735
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Collaborators:
Alzheimer Association
Nestlé Health Science SA
Information provided by (Responsible Party):
Université de Sherbrooke

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
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Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT04466735    
Other Study ID Numbers: 2020-3448
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No