A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Medium Chain Triglyceride INTervention for Alzheimer Disease (A MINT for AD)

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Dietary Supplement: Ketogenic medium chain triglyceride drink (MCT drink)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of mild-moderate Alzheimer disease (AD) Mini-Mental State Examination (MMSE) 16-26 Study partner available who has frequent contact with the participant Good visual and auditory acuity for neuropsychological testing Education including completion of at least six grades Must read and speak English fluently Antidepressants permitted, if stable for 4 weeks prior to screening (and participant is not currently depressed and does not have a history of major depression within the past 1 year) Cholinesterase inhibitors permitted, if stable for 12 weeks prior to screening Exclusion Criteria: Any significant neurologic disease other than AD History of Diabetes Mellitus type I or II Any contraindications to MRI or PET studies Major depression, bipolar disorder as described within the past 1 year. History of schizophrenia History of alcohol or substance abuse or dependence within the past 2 years Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol Current use of specific psychoactive medications Investigational amyloid lowering therapies are prohibited two months prior to screening and for the duration of the trial. Other investigational agents are prohibited one month prior to screening and for the duration of the trial. History of brain cancer

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketogenic medium chain triglyceride drink<br>Lactose-free skim milk drink containing 25 g of MCT oil per 250 ml. | Dietary Supplement: Ketogenic medium chain triglyceride drink (MCT drink)<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Lactose-free skim milk drink containing high-oleic sunflower oil in the equivalent amount of energy as the active arm. | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events, serious adverse events |  | From baseline to day 10 of intervention | 
| Plasma ketone concentrations in response to ascending dose of MCT | Plasma ketone concentrations of betahydroxybutyrate (BHB) and acetoacetate (AcAc) will be measured in response to MCT dosing from 10-50 grams daily. | Day 10 of intervention at 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, and 6 hours post MCT dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of MCT | To determine the MCT plasma concentration at stated time points in response to MCT dosing from 10-50 grams daily. | Day 10 of intervention at 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, and 6 hours post MCT dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medium chain triglyceride, MCT, coconut oil, MRI, PET, ketones