A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease

Not Applicable

• Conditions: Alzheimer's Disease
• Interventions: Dietary Supplement: Ketogenic medium chain triglyceride drink (MCT drink); Dietary Supplement: Placebo

• Registration Number: NCT02912936
• Lead Sponsor: University of British Columbia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-13
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-23
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-03
• Last Update Posted: 2018-12-05
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketogenic medium chain triglyceride drink	Ketogenic medium chain triglyceride drink (MCT drink)	Lactose-free skim milk drink containing 25 g of MCT oil per 250 ml.
Placebo	Placebo	Lactose-free skim milk drink containing high-oleic sunflower oil in the equivalent amount of energy as the active arm.

Primary Outcome Measures

Name	Time	Method
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	Day 10 of intervention at 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, and 6 hours post MCT dose	Plasma ketone concentrations of betahydroxybutyrate (BHB) and acetoacetate (AcAc) will be measured in response to MCT dosing from 10-50 grams daily.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Djavad Mowafaghian Centre for Brain Health; 🇨🇦 Vancouver, British Columbia, Canada