Coconut Oil for Alzheimer’s Disease:
Overall Status:
Recruiting
Brief Description:
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.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
|
60 Years
|
85 Years
|
Both
|
No
|
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Detailed Description:
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™.
Locations:
Lead Sponsor:
| Agency |
|---|
|
University of South Florida
|
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
|
Amanda G. Smith, MD
|
Principal Investigator
|
USF Health Byrd Alzheimer’s Institute
|
Study Contact:
| Name | Phone | |
|---|---|---|
|
Jill Smith
|
813-974-4355
|
ClinicalTrials.gov ID
NCT01883648 (follow link to view full record on ct.gov in new window)
Official Title:
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
Study Start Date:
June 2013
Study End Date:
December 2015
Disease Stage:
Early
Middle
Enrollment:
65
