Start: June 2013
End: February 1, 2017
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?
- 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.
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?
Lead: University of South Florida
Source: ClinicalTrials.gov ID: NCT01883648