NCT01782742

Bexarotene Amyloid Treatment for Alzheimer's Disease

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Retinoid X receptors (RXR) are nuclear receptors that have been linked to numerous metabolic pathways relevant to Alzheimer's disease (AD) and Aβ (harmful protein) production and removal. The study drug "bexarotene" is an FDA approved anti-cancer agent but is not approved for use in Alzheimer's disease. Bexarotene acts as an RXR agonist that has reduced Aβ (harmful protein) in the brain in experimental models of Alzheimer's disease. This study aims to determine the safety and effect on abnormal proteins found in the brain (based on brain scans) of 300 mg of "bexarotene" administered for one month compared to placebo (inactive agent).

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Bexarotene	Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo
DRUG	Placebo

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-08-01
• Completion: 2014-12-01
• First posted: 2013-02-04
• Last updated: 2016-02-12
• Results posted: 2016-02-12

Locations

1 site across 1 country: United States