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Coconut Oil for Alzheimer's Disease

Terminated

The goal of this randomized study is to determine the efficacy of coconut oil as a possible treatment for older adults with mild to moderate Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
60 Years 85 Years Both No
June 2013
February 1, 2017
65

  • Diagnosis of mild to moderate Alzheimer's disease
  • Study partner who spends at least 10 hours/week with the participant and can attend clinic visits and provide information about the participant
  • Mini-Mental State Examination score of 16-26; Rosen Modified Hachinski Ischemic score of 4
  • Must undergo ApoE genetic laboratory testing at the baseline visit
  • If taking Alzheimer's disease medications such as cholinesterase inhibitors (donepezil, rivastigmine, or galantamine) and/or memantine, must be on stable dose for at least 3 months prior to screening and agree not to change these medications during the course of the study, unless medically necessary
  • If taking memory-enhancing nonprescription supplements (for example, gingko biloba, huperzine, resveratrol, or docosahexaenoic acid), must be on stable dose for at least 3 months prior to screening and agree not to change these medications during the course of the study
  • Fluent in English

  • Significant neurological or medical disease, other than Alzheimer's, that may affect cognition
  • Current major psychiatric disorder or symptoms that could affect the participant's ability to complete the study
  • Geriatric Depression Scale score of more than 6 or suicidal ideation
  • Current, clinically significant chronic illness, such as uncontrolled diabetes or diabetic ketoacidosis, that is likely to result in deterioration of the participant's condition or safety during the study
  • History of clinically evident stroke, history of clinically significant carotid or vertebrobasilar stenosis, plaque or other risk factors for thromboembolic stroke
  • History of seizures
  • Myocardial infarction within the last 2 years; abnormal electrocardiogram at screening visit; uncontrolled hypertension within 6 months prior to screening
  • Cancer within the last 3 years, with the exception some carcinomas of the skin
  • Clinically significant infection within 30 days prior to screening.
  • Use of experimental or other investigational medications/devices for treatment within 90 days prior to screening
  • Laboratory findings of fasting total cholesterol greater than or equal to 240 mg/dL, fasting triglycerides greater than or equal to 200 mg/dL, or fasting glucose greater than or equal to 126 mg/dL
  • Other clinically significant abnormality seen on physical, neurological, laboratory, vital signs, or ECG examination (for example, changes consistent with recent infarction, ischemia, clinically significant arrhythmias, and clinically significant conduction defects)
  • Have taken coconut oil as a supplement or Axona (a medical food) within the last 30 days

This randomized, double-blind, placebo-controlled trial is designed to determine the effect of taking coconut oil on the cognition, functioning, and behavior of older adults with mild to moderate Alzheimer's. Participants will take a proprietary blend of coconut and medium-chain triglyceride oils, administered as a 1-ounce drink three times daily, for either Months 1-3 or Months 4-6 of the study; a placebo will be taken during the other 3-month period. The study medication formula is Cognate Nutritionals' Fuel for Thought.

Name City State Zip Status Primary Contact
USF Health Byrd Alzheimer's Institute
Tampa Florida 33613

University of South Florida

Name Role Affiliation
Amanda G. Smith, MD Principal Investigator USF Health Byrd Alzheimer's Institute

Name Phone Email
Jill Smith 813-974-4355 jsmith10@health.usf.edu

NCT01883648

A Randomized, Double-Blind, Placebo-Controlled, 6 Month Cross-Over Study to Evaluate the Efficacy of Coconut Oil (Fuel for Thought) Treatment for Subjects With Mild to Moderate Alzheimer's Disease