Cognitive Function 1, Social
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBulletproof Brain Octane
Medium chain triglyceride oil (MCT)
DIETARY_SUPPLEMENTPlacebo
Placebo (olive) oil
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind placebo controlled
Intervention model description
randomized, placebo control cross-over study, with an open label extension
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cognition | 15months | Mini Mental Status Examination (MMSE). 0-30. Higher score with higher cognitive function |
| Cognition | 15 months | Montreal Cognitive Assessment (MoCA) 0-30. Higher score with higher cognition |
| Behavior | 15 months | Neuropsychiatric Inventory (NPI) 0-96 Higher score with more behaviour problems |
| Function | 15 months | Katz Activities of Daily Living Scale 0-6 Higher score with poorer ADL function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Low density lipoprotein (LDL) mmol/l | 15 months | safety (% change from baseline) |
| maximum tolerated daily dose (ml) of MCT oil | 11 months | tolerability of MCT oil |
| Incidence of treatment-emergent Adverse events | 15 months | safety. Mild, moderate or severe events. |
| Dual Energy Absorptiometry (DXA) Body fat | 15 months | safety (% change from baseline) |
| 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) |
| Serum Triglyceride mmol/l | 15 months | safety (% change from baseline) |
Outcome results
None listed