Abstract
Background: Alzheimer’s disease (AD)’s pharmacotherapy is limited, with anecdotal reports claiming some usefulness of cold pressed coconut oil. Aims and Objectives: To study the effect of cold pressed coconut oil on cognition and behavior of AD patients who are treatment naïve or stabilized on cholinesterase inhibitors or memantine for at least 3 months with a mini-mental state examination (MMSE) score of 10-24. Materials and Methods: An investigator initiated pilot randomized controlled trial studied the effect of cold pressed coconut oil on cognition and behavior of AD patients. Minimum sample size was calculated assuming an increase of 30% in MMSE scores in the experimental group with 95% confidence interval and 80% power to be 20 at each experimental and control groups. Efficacy was measured using MMSE, clock drawing test (CDT), neuropsychiatric inventory questionnaire at baseline, 3 and 6 months, with safety profile monitored by electrocardiogram, and laboratory investigations at baseline and at 6 months. Results: 40 individuals out of 99 screened were enrolled, with no significant differences in cognitive level between the intervention and control group at baseline. At 6 months, the control group showed significant (P = 0.035) improvement in CDT. Diarrhea, the most common adverse event caused high dropout in intervention group. Conclusion: Cold pressed coconut oil did not improve cognition or behavior in AD patients.