A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease

Alzheimer's Disease Clinical Trial

— MINT-01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02912936
• Other study ID #: H15-02537
• Status: Recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 2019

Study information

• Verified date: December 2018
• Source: University of British Columbia
• Contact: Penny Slack, MSc
• Phone: 604-822-6379
• Email: pslack[@]mail.ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Dietary Supplement:
• Ketogenic medium chain triglyceride drink (MCT drink)
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.
• Placebo
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.

Locations

Country	Name	City	State
Canada	Djavad Mowafaghian Centre for Brain Health	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cerebral metabolic rate of glucose in response to a ketogenic MCT drink	Assess changes in metabolic rate of glucose by 18F fludeoxyglucose positron emission tomography (FDG-PET) in response to escalating doses of MCT (10-50grams daily) in patients with Alzheimer's disease	Baseline and day 10 of intervention
Other	Cerebral blood flow in response to a ketogenic MCT drink	Assess changes in brain blood flow using MRI (Arterial Spin Labeling) in response to escalating doses of MCT (10-50 grams daily) in patients with Alzheimer's disease	Baseline and day 10 of intervention
Other	Changes in MR Spectroscopy (N-acetylaspartate, glutamate, glutamine) in response to a ketogenic MCT drink	Assess changes in brain chemistry (measuring (N-acetylaspartate, glutamate, glutamine) in response to MCT treatment across a dose range of 10-50grams daily	Baseline and day 10 of intervention
Other	Changes in daily physical activity in response to a ketogenic MCT drink	Changes in behavior rhythms (activity level and sleep/rest) in response to MCT treatment across a dose range of 10-50grams daily, using an actigraphy watch.	Baseline and day 10 of intervention
Primary	Number of participants with adverse events, serious adverse events		From baseline to day 10 of intervention
Primary	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	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