Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.

Not Applicable

Completed

• Conditions: Cognitive Function 1, Social
• Interventions: Dietary Supplement: Bulletproof Brain Octane; Dietary Supplement: Placebo

• Registration Number: NCT04396015
• Lead Sponsor: University of Alberta

Brief Summary

The present study is being done in a scientifically rigorous manner, using readily available MCT oil (refined from coconut oil) versus a placebo oil to assess any cognitive and functional benefits for AD patients.

Detailed Description

The proposed study, is a randomized placebo controlled cross-over study for 6 months, with an open label extension for another 6 months designed to test the benefits and safety of MCT oil in patients with established AD. It will be the first study on MCT oil ever done with this design, and for this duration in AD.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2017-10-05
• Primary Completion: 2019-01
• Study Completion: 2019-03
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-15
• Last Update Submitted: 2020-05-15
• Study First Posted: 2020-05-20
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients >49years with a clinical diagnosis of AD
• Mini Mental Status Examination (MMSE) score 10-29/30
• on stable dose of medications for 3 months (AChEI, memantine and antidepressants allowed)
• able to speak English
• patient or designate able to sign informed consent
• stable chronic medical conditions (Heart disease, thyroid disease)
• reliable caregiver

Exclusion Criteria

• age <50 years
• medically unstable
• unable to swallow liquids
• diagnosis of diabetes mellitus
• residence in a nursing/long term care home
• allergy to coconut
• allergy to olive oil

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
open label extension	Bulletproof Brain Octane	6 months of MCT oil.
medium chain triglyceride (MCT) vs placebo	Placebo	MCT or placebo (olive oil) for 4 months. Crossover at 4 months
medium chain triglyceride (MCT) vs placebo	Bulletproof Brain Octane	MCT or placebo (olive oil) for 4 months. Crossover at 4 months

Primary Outcome Measures

Name	Time	Method
Behavior	15 months	Neuropsychiatric Inventory (NPI) 0-96 Higher score with more behaviour problems
cognition	15 months	Cognigram (Cogstate) 0-200. Higher score with higher cognitive function
Cognition	15 months	Montreal Cognitive Assessment (MoCA) 0-30. Higher score with higher cognition
Function	15 months	Katz Activities of Daily Living Scale 0-6 Higher score with poorer ADL function

Secondary Outcome Measures

Name	Time	Method
maximum tolerated daily dose (ml) of placebo (olive) oil	4 months	tolerability of placebo oil
Serum cholesterol mmol/l	15 months	safety (% change from baseline)
maximum tolerated daily dose (ml) of MCT oil	11 months	tolerability of MCT oil
Serum Low density lipoprotein (LDL) mmol/l	15 months	safety (% change from baseline)
Dual Energy Absorptiometry (DXA) Body fat	15 months	safety (% change from baseline)
Incidence of treatment-emergent Adverse events	15 months	safety. Mild, moderate or severe events.
Serum Triglyceride mmol/l	15 months	safety (% change from baseline)