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Bexarotene Amyloid Treatment for Alzheimer's Disease (BEAT-AD)

  • Completed

This study aims to determine the safety and effect on the brain of the drug bexarotene as a possible treatment for Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 90 Years Both No
February 2013
March 2014
20
  • 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
  • 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

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.

Name City State Zip Status Primary Contact
Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas Nevada 89106

The Cleveland Clinic

Name Role Affiliation
Jeffrey L. Cummings, MD, ScD Principal Investigator The Cleveland Clinic

Name Phone Extension Email
Samuel J. Hickson 702-685-7073 hicksos@ccf.org

A Double Blind Placebo Controlled Randomized Study to Evaluate the Efficacy and Safety of Bexarotene in Patients With Mild to Moderate Alzheimer`s Disease