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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| medium chain triglyceride (MCT) vs placebo | Placebo Comparator | MCT or placebo (olive oil) for 4 months. Crossover at 4 months |
|
| open label extension | Other | 6 months of MCT oil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bulletproof Brain Octane | Dietary Supplement | Medium chain triglyceride oil (MCT) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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randomized, placebo control cross-over study, with an open label extension
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Double blind placebo controlled
| Placebo | Dietary Supplement | Placebo (olive) 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 |