A Study to Evaluate the Effect of Bexarotene on Beta-Amyloid and Apolipoprotein E Metabolism in Healthy Subjects

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this proof of mechanism pilot clinical trial is to determine if the RXR agonist bexarotene acts in humans to alter the CSF levels of apoE and alter the clearance of Amyloid-Beta

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ReXceptor, Inc.
• Treatments: Bexarotene

Criteria

Inclusion Criteria:

• Young healthy adults (age 21-50)

• APOE3/3 genotype

Exclusion Criteria:

• Contraindications for blood or CSF sampling

• Bleeding disorder or taking anticoagulants/antiplatelets

• Chronic active infection

• Blood donation within the past month

• Active drug/alcohol dependence or abuse history with in the last 12 months

• Thyroid dysfunction

• High triglycerides (>3.5 mmol/L)

• High cholesterol (>4.0 mmoL/L)

• Leukopenia, including low neutrophil count (<3 x 10^9/L)

• Neurological or psychiatric disorders

• Homeless or prisoner

• Pregnancy

• Incapable of self-informed consent

• Blood borne disease (HIV, Hepatitis)

• Actively smoking and incapable of using nicotine patches

• Known drug allergy to pain medication or local anesthetic

• Subjects that have participated in another study in the last 30 days

• Abnormalities in lumbar spine previously known within 12 months

• APOE2 or APOE4 allele

• Abnormal EKG