A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease
NCT02912936 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43
Last updated 2026-04-23
Summary
The purpose of this study is to determine safety, tolerability, and pharmacokinetics/dynamics of a ketogenic dietary supplement containing medium chain triglycerides (MCTs) in patients with Alzheimer disease (AD). Novel imaging and laboratory biomarkers in response to this intervention will also be explored. In addition, a sub-study was added to the UBC-approved protocol on November 29, 2016, prior to enrollment of the first FTD participant in April 2017. The FTD sub-study was designed as a pilot study to evaluate the safety and tolerability of MCT supplementation in participants with nonfluent/agrammatic variant primary progressive aphasia (nfvPPA).
Conditions
- Alzheimer's Disease
- Primary Progressive Non-fluent Aphasia
- Frontotemporal Dementia (FTD)
Interventions
- DIETARY_SUPPLEMENT
-
Ketogenic medium chain triglyceride drink (MCT drink)
10 days supplementation with the MCT drink. Participants in dose group 1 will be assigned to 10 g per day, those in dose group 2 will be assigned 20 g per day, those in dose group 3 will be assigned 30 g per day, those in dose group 4 will be assigned 40 g per day, and those in dose group 5 will be assigned 50 g per day. The drink will be taken in the morning and evening. Participants will be enrolled 8 per group in ascending order.
- DIETARY_SUPPLEMENT
-
Placebo
10 days supplementation with the placebo drink. Participants in dose group 1 will be assigned to 10 g per day, those in dose group 2 will be assigned 20 g per day, those in dose group 3 will be assigned 30 g per day, those in dose group 4 will be assigned 40 g per day, and those in dose group 5 will be assigned 50 g per day. The drink will be taken in the morning and evening. Participants will be enrolled 8 per group in ascending order.
Sponsors & Collaborators
-
Université de Sherbrooke
collaborator OTHER -
University of British Columbia
lead OTHER
Principal Investigators
-
Haakon Nygaard, MD, PhD · University of British Columbia
-
Howard Feldman, MD · University of California, San Diego
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-30
- Primary Completion
- 2020-02-04
- Completion
- 2020-03-01
Countries
- Canada
Study Locations
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