Bexarotene Amyloid Treatment for Alzheimer's Disease (BEAT-AD)
Bexarotene Amyloid Treatment for Alzheimer's Disease (BEAT-AD)
Overall Status:
Recruiting
Brief Description:
This study aims to determine the safety and effect on the brain of the drug bexarotene as a possible treatment for Alzheimer's disease.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
50 Years | 90 Years | Both | No |
Inclusion Criteria:
- Diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- Willing and able to comply with study visits, treatment plan, laboratory tests, brain imaging, and other procedures
- Positive 18F-AV-45 PET scan
- Mini-Mental State Examination (MMSE) score between 10-20 inclusive
- Study partner who can comply with all required procedures
- Women must be postmenopausal
- At least 8 years of education; able in pre-Alzheimer's condition to read, write, and communicate effectively in English
- If taking a cholinesterase inhibitor and/or memantine, dose must be stable for at least 4 weeks before joining trials
- Normal laboratory findings at screening, including CBC, chemistry panel, serum lipids, liver functions, TSH, and vitamin B12
- Must consent to ApoE genotyping
Exclusion Criteria:
- Any clinically relevant neurological disorder, other than Alzheimer's, capable of producing a dementia syndrome, including Parkinson's disease, stroke, vascular dementia, dementia with Lewy bodies, and frontotemporal dementia
- Four or more micro-hemorrhages (amyloid-related imaging abnormalities) found on screening MRI or other amyloid-related imaging abnormalities
- History of cancer within the past 5 years with the exception of basal cell or squamous cell cancer, in-situ cervical cancer, or localized prostate cancer; radiotherapy within the past year
- History of seizure within the past 3 years
- Any contraindication to brain MRI or PET scan, such as inability to lie flat and still for the duration of the scan or hypersensitivity reaction to PET ligand or imaging agent; PET scan within the past 12 months
- Unstable medical illness, including hypertension, congestive heart failure, chronic obstructive pulmonary disease, renal failure, liver failure, or other organ-related condition
- Other clinically important abnormality or health condition as shown by vital signs, physical examination, neurologic examination, laboratory results, or electrocardiogram examination that could compromise the study or be detrimental to the subject
- Previously took bexarotene; allergy to bexarotene
- Participation in an investigational drug or device study within 30 days prior to second visit
- Treatment with immunomodulators for Alzheimer's disease (such as vaccines or antibodies) within 6 months prior to second visit
Detailed Description:
In this Phase II trial, participants will receive either 300 mg of the anti-cancer drug bexarotene or a placebo for 1 month and undergo brain scans to determine the drug's effects on the brain. Bexarotene acts to reduce harmful beta-amyloid protein deposits in the brain in experimental models of Alzheimer's disease by inhibiting retinoid X receptors, nuclear receptors that have been linked to numerous metabolic pathways relevant to Alzheimer's disease and beta-amyloid production and removal.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 36.1922841, -115.1592718 | Cleveland Clinic Lou Ruvo Center for Brain Health | Las Vegas | Nevada | 89106 | Recruiting |
Lead Sponsor:
| Agency |
|---|
The Cleveland Clinic |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Jeffrey L. Cummings, MD, ScD | Principal Investigator | The Cleveland Clinic |
Study Contact:
| Name | Phone | |
|---|---|---|
Samuel J. Hickson | 702-685-7073 |
Locations
ClinicalTrials.gov ID
NCT01782742 (follow link to view full record on ct.gov in new window)
Official Title:
A Double Blind Placebo Controlled Randomized Study to Evaluate the Efficacy and Safety of Bexarotene in Patients With Mild to Moderate Alzheimer's Disease
Study Start Date:
February 2013
Study End Date:
March 2014
Disease Stage:
Early
Middle
Enrollment:
20
