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

Study Overview
=================
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.

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

Conditions
-----------------
Cognitive Function 1, Social

Intervention / Treatment
-----------------
* Dietary Supplement: Bulletproof Brain Octane
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: randomized, placebo control cross-over study, with an open label extension
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: medium chain triglyceride (MCT) vs placebo<br>MCT or placebo (olive oil) for 4 months. Crossover at 4 months | Dietary Supplement: Bulletproof Brain Octane<br>* Medium chain triglyceride oil (MCT)<br>Dietary Supplement: Placebo<br>* Placebo (olive) oil<br>|
| Other: open label extension<br>6 months of MCT oil. | Dietary Supplement: Bulletproof Brain Octane<br>* Medium chain triglyceride oil (MCT)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognition | Mini Mental Status Examination (MMSE). 0-30. Higher score with higher cognitive function | 15months | 
| Cognition | Montreal Cognitive Assessment (MoCA) 0-30. Higher score with higher cognition | 15 months | 
| cognition | Cognigram (Cogstate) 0-200. Higher score with higher cognitive function | 15 months | 
| Behavior | Neuropsychiatric Inventory (NPI) 0-96 Higher score with more behaviour problems | 15 months | 
| Function | Katz Activities of Daily Living Scale 0-6 Higher score with poorer ADL function | 15 months | 

Secondary Outcome Measures

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