Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.
Primary Purpose
Cognitive Function 1, Social
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bulletproof Brain Octane
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Function 1, Social
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Other
Arm Label
medium chain triglyceride (MCT) vs placebo
open label extension
Arm Description
MCT or placebo (olive oil) for 4 months. Crossover at 4 months
6 months of MCT oil.
Outcomes
Primary Outcome Measures
cognition
Mini Mental Status Examination (MMSE). 0-30. Higher score with higher cognitive function
Cognition
Montreal Cognitive Assessment (MoCA) 0-30. Higher score with higher cognition
cognition
Cognigram (Cogstate) 0-200. Higher score with higher cognitive function
Behavior
Neuropsychiatric Inventory (NPI) 0-96 Higher score with more behaviour problems
Function
Katz Activities of Daily Living Scale 0-6 Higher score with poorer ADL function
Secondary Outcome Measures
maximum tolerated daily dose (ml) of MCT oil
tolerability of MCT oil
maximum tolerated daily dose (ml) of placebo (olive) oil
tolerability of placebo oil
Serum cholesterol mmol/l
safety (% change from baseline)
Serum Triglyceride mmol/l
safety (% change from baseline)
Serum Low density lipoprotein (LDL) mmol/l
safety (% change from baseline)
Dual Energy Absorptiometry (DXA) Body fat
safety (% change from baseline)
Incidence of treatment-emergent Adverse events
safety. Mild, moderate or severe events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04396015
Brief Title
Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.
Official Title
Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Function 1, Social
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
randomized, placebo control cross-over study, with an open label extension
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind placebo controlled
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
medium chain triglyceride (MCT) vs placebo
Arm Type
Placebo Comparator
Arm Description
MCT or placebo (olive oil) for 4 months. Crossover at 4 months
Arm Title
open label extension
Arm Type
Other
Arm Description
6 months of MCT oil.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bulletproof Brain Octane
Intervention Description
Medium chain triglyceride oil (MCT)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo (olive) oil
Primary Outcome Measure Information:
Title
cognition
Description
Mini Mental Status Examination (MMSE). 0-30. Higher score with higher cognitive function
Time Frame
15months
Title
Cognition
Description
Montreal Cognitive Assessment (MoCA) 0-30. Higher score with higher cognition
Time Frame
15 months
Title
cognition
Description
Cognigram (Cogstate) 0-200. Higher score with higher cognitive function
Time Frame
15 months
Title
Behavior
Description
Neuropsychiatric Inventory (NPI) 0-96 Higher score with more behaviour problems
Time Frame
15 months
Title
Function
Description
Katz Activities of Daily Living Scale 0-6 Higher score with poorer ADL function
Time Frame
15 months
Secondary Outcome Measure Information:
Title
maximum tolerated daily dose (ml) of MCT oil
Description
tolerability of MCT oil
Time Frame
11 months
Title
maximum tolerated daily dose (ml) of placebo (olive) oil
Description
tolerability of placebo oil
Time Frame
4 months
Title
Serum cholesterol mmol/l
Description
safety (% change from baseline)
Time Frame
15 months
Title
Serum Triglyceride mmol/l
Description
safety (% change from baseline)
Time Frame
15 months
Title
Serum Low density lipoprotein (LDL) mmol/l
Description
safety (% change from baseline)
Time Frame
15 months
Title
Dual Energy Absorptiometry (DXA) Body fat
Description
safety (% change from baseline)
Time Frame
15 months
Title
Incidence of treatment-emergent Adverse events
Description
safety. Mild, moderate or severe events.
Time Frame
15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.
We'll reach out to this number within 24 hrs