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CompletedPhase 1

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

A Randomized Controlled Study to Evaluate the Effect of Bexarotene - an RXR Agonist - on Beta-Amyloid and Apolipoprotein E Metabolism in Healthy Subjects

Lead sponsor

ReXceptor, Inc.

Asset

Bexarotene

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 21-50

Primary endpoint

•Area under the effect curve for newly generated beta-Amyloid (clearance phase)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02061878

Org study IDREXCEPTOR-101

Timeline

Milestones

Study first posted2014-02-13estimated

Study start2014-08 (month precision)

Primary completion2014-11actual (month precision)

Study completion2014-11actual (month precision)

Last update posted2015-08-13estimated

Assets

Drug assets

Bexarotene

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age21 Years

Maximum age50 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Amyloid biomarkers

3 endpoints

Primary/protocol endpoint

Area under the effect curve for newly generated beta-Amyloid (clearance phase),

Time frame:21 - 48 hr

descriptive

Secondary/protocol endpoint

Fractional clearance rate of beta-Amyloid peptide in CNS

Time frame:21 - 36 hrs

concentration, descriptive

Other/protocol endpoint

Exploratory Endpoint

Time frame:5 days

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Ghosal K, Haag M, Verghese PB, West T, Veenstra T, Braunstein JB, Bateman RJ, Holtzman DM, Landreth GE. A randomized controlled study to evaluate the effect of bexarotene on amyloid-beta and apolipoprotein E metabolism in healthy subjects. Alzheimers Dement (N Y). 2016 Jun 17;2(2):110-120. doi: 10.1016/j.trci.2016.06.001. eCollection 2016 Jun.
PMID29067298via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.