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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Medium chain triglyceride oil (MCT)
Placebo (olive) oil
cognition
Mini Mental Status Examination (MMSE). 0-30. Higher score with higher cognitive function
Time frame: 15months
Cognition
Montreal Cognitive Assessment (MoCA) 0-30. Higher score with higher cognition
Time frame: 15 months
cognition
Cognigram (Cogstate) 0-200. Higher score with higher cognitive function
Time frame: 15 months
Behavior
Neuropsychiatric Inventory (NPI) 0-96 Higher score with more behaviour problems
Time frame: 15 months
Function
Katz Activities of Daily Living Scale 0-6 Higher score with poorer ADL function
Time frame: 15 months
maximum tolerated daily dose (ml) of MCT oil
tolerability of MCT oil
Time frame: 11 months
maximum tolerated daily dose (ml) of placebo (olive) oil
tolerability of placebo oil
Time frame: 4 months
Serum cholesterol mmol/l
safety (% change from baseline)
Time frame: 15 months
Serum Triglyceride mmol/l
safety (% change from baseline)
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Time frame: 15 months
Serum Low density lipoprotein (LDL) mmol/l
safety (% change from baseline)
Time frame: 15 months
Dual Energy Absorptiometry (DXA) Body fat
safety (% change from baseline)
Time frame: 15 months
Incidence of treatment-emergent Adverse events
safety. Mild, moderate or severe events.
Time frame: 15 months