A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease (MINT-01)

University of British Columbia

Status: Unknown

Conditions: Alzheimer's Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Ketogenic medium chain triglyceride drink (MCT drink)

Study type: Interventional

Funder types: Other

Identifiers

NCT02912936

H15-02537

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Ketogenic medium chain triglyceride drink

Experimental group

Description:

Lactose-free skim milk drink containing 25 g of MCT oil per 250 ml.

Treatment:

Dietary Supplement: Ketogenic medium chain triglyceride drink (MCT drink)

Placebo

Placebo Comparator group

Description:

Lactose-free skim milk drink containing high-oleic sunflower oil in the equivalent amount of energy as the active arm.

Treatment:

Dietary Supplement: Placebo