This is a randomized, cross over study to determine the efficacy of coconut oil in subjects with mild to moderate Alzheimer's disease.
This is a randomized, double-blind, placebo-controlled, cross over study to determine the efficacy of coconut oil (a proprietary blend of coconut and medium chain triglyceride oils, administered orally three times daily) to subjects with Alzheimer's disease who have been screened for ApoE 4 allele. The study medication formula is Cognate Nutritionals Fuel for Thought™. Approximately 65 subjects will be treated with a coconut oil beverage (Fuel for Thought™) or placebo for three months, and then given a 3-5 day interim wash out period. After this, subjects will resume with three months treatment in opposite treatment arm. Total treatment period is 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
21
There are 2 treatment arms: Fuel for Thought™ and placebo, with a treatment allocation of 1:1. After 3 months of treatment in one group, subjects will have a 3-5 day wash-out period before receiving the alternate (opposite) treatment for 3 months.
There are 2 treatment arms: Fuel for Thought™ and placebo, with a treatment allocation of 1:1. After 3 months of treatment in one group, subjects will have a 3-5 day wash-out period before receiving the alternate (opposite) treatment for 3 months.
USF Health Byrd Alzheimer's Institute
Tampa, Florida, United States
Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in cognitive testing (ADAS-cog, MMSE, Category/Letter Fluency)
Time frame: Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in cognitive testing (ADAS-cog, MMSE, Category/Letter Fluency)
Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in Trails A & B cognitive testing
Time frame: Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in Trails A & B cognitive testing
Change from baseline to Month 3 of each treatment phase (a 3 month period of time) on Geriatric Depression Scale
Time frame: Change from baseline to Month 3 of each treatment phase (a 3 month period of time) on Geriatric Depression Scale
Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in behaviors measured by Neuropsychiatric Inventory
Time frame: Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in behaviors measured by Neuropsychiatric Inventory
Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in functional ability measured by Activities of Daily Living (ADCS-ADLs)
Time frame: Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in functional ability measured by Activities of Daily Living (ADCS-ADLs)
Measure changes in Ketone & C-Reactive Protein assays from research blood samples throughout study during the 2 treatment periods from Baseline to Month 6 (change during a total 6 month period of time).
Time frame: Measure changes in Ketone & C-Reactive Protein assays from research blood samples throughout study during the 2 treatment periods from Baseline to Month 6 (change during a total 6 month period of time).
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Adverse events related to coconut oil usage during 6 months of treatment periods (change during a total 6 month period of time).
Time frame: Adverse events related to coconut oil usage during 6 months of treatment periods (change during a total 6 month period of time).