Start: June 2013
End: February 1, 2017
Enrollment: 65
What Is This Study About?
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.
Do I Qualify To Participate in This Study?
Must have:
- 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
Must NOT have:
- 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
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Study Contact
Jill Smith
Need Help?
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
| Florida |
|
USF Health Byrd Alzheimer's Institute
Tampa, FL 33613
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Lead: University of South Florida
Source: ClinicalTrials.gov ID: NCT01883648