Study to Evaluate Coconut Oil for Alzheimer's Disease

NCT01883648 | Terminated Phase 2 DMC

• 1 other identifier: Byrd AD-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, cross over study to determine the efficacy of coconut oil in subjects with mild to moderate Alzheimer's disease.

Conditions

Alzheimer's Disease

Keywords

Mild to Moderate Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in cognitive testing (ADAS-cog, MMSE, Category/Letter Fluency)

  Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in cognitive testing (ADAS-cog, MMSE, Category/Letter Fluency)

Secondary Outcomes (6)

• Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in Trails A & B cognitive testing

  Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in Trails A & B cognitive testing

• Change from baseline to Month 3 of each treatment phase (a 3 month period of time) on Geriatric Depression Scale

  Change from baseline to Month 3 of each treatment phase (a 3 month period of time) on Geriatric Depression Scale

• Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in behaviors measured by Neuropsychiatric Inventory

  Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in behaviors measured by Neuropsychiatric Inventory

• Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in functional ability measured by Activities of Daily Living (ADCS-ADLs)

  Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in functional ability measured by Activities of Daily Living (ADCS-ADLs)

• Measure changes in Ketone & C-Reactive Protein assays from research blood samples throughout study during the 2 treatment periods from Baseline to Month 6 (change during a total 6 month period of time).

  Measure changes in Ketone & C-Reactive Protein assays from research blood samples throughout study during the 2 treatment periods from Baseline to Month 6 (change during a total 6 month period of time).

Study Arms (2)

Coconut Oil Beverage

EXPERIMENTAL

The treatment will consist of a 1.25 oz serving size taken orally, two times daily by subjects. This treatment arm will last 3 months.

Drug: Coconut Oil Beverage

Placebo Beverage

PLACEBO COMPARATOR

The treatment will consist of a 1.25 oz serving size taken orally, two times daily by subjects.This will similar in look and taste but not have the same ingredients of the actual coconut oil beverage. This treatment arm will last 3 months.

Other: Placebo Beverage

Interventions

Coconut Oil Beverage DRUG

There are 2 treatment arms: Fuel for Thought™ and placebo, with a treatment allocation of 1:1. After 3 months of treatment in one group, subjects will have a 3-5 day wash-out period before receiving the alternate (opposite) treatment for 3 months.

Also known as: Fuel for Thought (TM)

Coconut Oil Beverage

Placebo Beverage OTHER

There are 2 treatment arms: Fuel for Thought™ and placebo, with a treatment allocation of 1:1. After 3 months of treatment in one group, subjects will have a 3-5 day wash-out period before receiving the alternate (opposite) treatment for 3 months.

Placebo Beverage

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 55 to 90 years with a diagnosis of mild to moderate Alzheimer's disease
• Informed consent signed and dated by subject (or legally authorized representative).
• Subjects must have a study partner must also consent to participate in the study, who they spend at least 10 hours/week with during the study. The study partner must attend applicable clinic visits and provide information about the subject.
• Subject must have a screening Mini-Mental State Examination score of 16-26.
• Subjects must have a Rosen Modified Hachinski Ischemic score of ≤4.
• Subject must undergo ApoE genetic laboratory testing at the baseline visit.
• Subject must be willing and able to take study medication (or placebo) for the duration of the study.
• Subject must be stable on all memory enhancing medications including cholinesterase inhibitors (including donepezil, rivastigmine, and galantamine) and NMDA antagonist (memantine) for at least 3 months prior to screening and agree not to change these medications during the course of their participation, unless medically necessary.
• Subject must be stable on all memory enhancing nonprescription supplements (including gingko biloba, huperzine, resveratrol, or docosahexaenoic acid) for at least 3 months prior to screening and agree not to change these medications during the course of their participation.
• As judged by Investigator, the subject and study partner will be compliant and have a high probability of completing the study, including all scheduled evaluations and required tests.
• Be fluent in English.

You may not qualify if:

• Has significant neurological or medical disease, other than AD, that may affect cognition, for example, history or evidence of hydrocephalus, or uncontrolled hypo- or hyperthyroidism.
• Current, clinically significant major psychiatric disorder (eg, major depressive disorder) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSMIV), or symptoms (eg, hallucinations) that could affect the subject's ability to complete the study.
• Geriatric depression scale score of more than 6 or has suicidal ideation.
• Current clinically significant chronic illness that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study, including uncontrolled diabetes. Subjects with a history of diabetic ketoacidosis will also be excluded. Other cases of diabetes will be decided at the discretion of the study physicians. Subjects with diabetes controlled with exercise and diet may be screened and admission to study will depend on their screening safety laboratory assessments.
• History of clinically evident stroke or history of clinically significant carotid or vertebrobasilar stenosis or plaque and other risk factors for thromboembolic stroke (e.g atrial fibrillation, clinically significant low ventricular output, atrial septal defect).
• History of seizures.
• Clinically significant infection within the last 30 days (eg, chronic persistent or acute infection \[eg, upper respiratory infection, urinary tract infection\]),prior to screening.
• Myocardial infarction within the last 2 years.
• Abnormal screening visit electrocardiogram (ECG), in the opinion of the investigator.
• Uncontrolled hypertension within the last 6 months prior to screening.
• History of cancer within the last 3 years, with the exception of nonmetastatic basal cell carcinoma and squamous cell carcinoma of the skin. (Note: cancer must be in remission with no signs of progression.)
• 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
• Laboratory findings of fasting triglycerides greater than or equal to 200 mg/dL
• Laboratory findings of fasting glucose greater than or equal to 126 mg/dL

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

USF Health Byrd Alzheimer's Institute

Tampa, Florida, 33613, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Amanda G Smith, MD

  USF Health Byrd Alzheimer's Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 21, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 28, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)