A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease (NCT02912936) | Clinical Trial Compass
CompletedNot Applicable
A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease
Canada43 participantsStarted 2016-09
Plain-language 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).
Who can participate
Age range
20 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Dx of nonfluent/agrammatic variant primary progressive aphasia
. Older than 19 years
. Stability of permitted medications for 4 weeks. In particular, subjects may:
. Study partner is available who has frequent contact with the subject (e.g. an average of 8 hours per week or more), and can accompany the subject to all clinic visits for the duration of the protocol.
. Females are not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile).
. PET scan consistent with FTD (showing frontal hypoperfusion +/- temporal hypoperfusion)
. MRI consistent with FTD/PNFA
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with adverse events, serious adverse events
Timeframe: From baseline to day 10 of intervention
2
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
3
Safety and tolerability of SCCF-3012
Timeframe: Baseline to Month 6
4
Pharmacodynamic ketone response
Timeframe: Baseline, Month 3, Month 6 (each at pre-dose, 1 hour, and 4 hours post-dose)