A Study to Evaluate the Effect of Bexarotene on Beta-Amyloid and Apolipoprotein E Metabolism in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 21 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | August 2014 |
| End Date: | November 2014 |
A Randomized Controlled Study to Evaluate the Effect of Bexarotene - an RXR Agonist - on Beta-Amyloid and Apolipoprotein E Metabolism in Healthy Subjects
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
RXR agonist bexarotene acts in humans to alter the CSF levels of apoE and alter the
clearance of Amyloid-Beta
This is a double blinded, investigational drug study designed to measure the effect of
bexarotene on the clearance of Aβ total and production of apoE in the human brain of young,
healthy individuals with the APOE3/3 genotype. From the date of initial subject recruitment
to the issuance of a final study report and closeout activities, the expected total study
duration is 6 to 10 months.
Each participant will be screened for eligibility and randomized to receive either oral
bexarotene or placebo control ("Test Article").The study has the potential to demonstrate
the pharmacodynamic properties of a novel treatment approach to Alzheimer's disease. The
primary biomarker measurements obtained from this study are believed to be highly dynamic
and able to provide a rapid read-out of the biologic activity of the candidate therapeutic
under study. In addition, exploratory analysis will involve a proteomics-based screen to
identify proteins within both blood and CSF that are induced by the Test Article, thereby
potentially identifying new biomarkers that can be used in future clinical trials to
demonstrate bexarotene action and target engagement.
bexarotene on the clearance of Aβ total and production of apoE in the human brain of young,
healthy individuals with the APOE3/3 genotype. From the date of initial subject recruitment
to the issuance of a final study report and closeout activities, the expected total study
duration is 6 to 10 months.
Each participant will be screened for eligibility and randomized to receive either oral
bexarotene or placebo control ("Test Article").The study has the potential to demonstrate
the pharmacodynamic properties of a novel treatment approach to Alzheimer's disease. The
primary biomarker measurements obtained from this study are believed to be highly dynamic
and able to provide a rapid read-out of the biologic activity of the candidate therapeutic
under study. In addition, exploratory analysis will involve a proteomics-based screen to
identify proteins within both blood and CSF that are induced by the Test Article, thereby
potentially identifying new biomarkers that can be used in future clinical trials to
demonstrate bexarotene action and target engagement.
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
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