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).
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Number of participants with adverse events, serious adverse events
Timeframe: From baseline to day 10 of intervention
Plasma ketone concentrations in response to ascending dose of MCT
Timeframe: Day 10 of intervention at 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, and 6 hours post MCT dose
Safety and tolerability of SCCF-3012
Timeframe: Baseline to Month 6
Pharmacodynamic ketone response
Timeframe: Baseline, Month 3, Month 6 (each at pre-dose, 1 hour, and 4 hours post-dose)