Clinical trial NCT02912936: A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease
Official title: A Medium Chain Triglyceride INTervention for Alzheimer Disease (A MINT for AD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer's Disease
Keywords: medium chain triglyceride
MCT
coconut oil
MRI
PET
ketones
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Université de Sherbrooke
First posted: 2016-09-23
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events, serious adverse events
timeFrame: From baseline to day 10 of intervention
measure: 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
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) 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
Other outcomes:
measure: Cerebral metabolic rate of glucose in response to a ketogenic MCT drink
timeFrame: Baseline and day 10 of intervention
measure: Cerebral blood flow in response to a ketogenic MCT drink
timeFrame: Baseline and day 10 of intervention
measure: Changes in MR Spectroscopy (N-acetylaspartate, glutamate, glutamine) in response to a ketogenic MCT drink
timeFrame: Baseline and day 10 of intervention
measure: Changes in daily physical activity in response to a ketogenic MCT drink
timeFrame: Baseline and day 10 of intervention
Locations:
city: Vancouver
country: Canada
facility: Djavad Mowafaghian Centre for Brain Health
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Haakon Nygaard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Howard Feldman, MD
role: PRINCIPAL_INVESTIGATOR
References: