NCT02061878

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

3 months

First QC Date

February 5, 2014

Last Update Submit

August 11, 2015

Conditions

Alzheimer's Disease

Keywords

ApoEbeta-amyloid

Outcome Measures

Primary Outcomes (1)

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

    Area under the effect curve from 21-48h for newly generated beta-Amyloid (clearance phase), which is computed for each individual as the area under the curve of the clearance portion of the labeled beta-Amyloid curve between 21 hour and 48 hours, normalized by plasma free leucine levels.

    21 - 48 hr

Secondary Outcomes (1)

  • Fractional clearance rate of beta-Amyloid peptide in CNS

    21 - 36 hrs

Other Outcomes (1)

  • Exploratory Endpoint

    5 days

Study Arms (2)

Bexarotene

EXPERIMENTAL

The subjects will be administered three (3) capsules of Targretin™ (75 mg/capsule) on a twice daily basis (450 mg/day) for five days

Drug: Bexarotene

Placebo

PLACEBO COMPARATOR

The subjects will be administered three (3) capsules of Avicel PH on a twice daily basis (450 mg/day) for five days.

Drug: Placebo

Interventions

BexaroteneDRUG

Marketed product Targretin® soft gelatin capsule (75mg/capsule) is over-encapsulated in a size AA-el Swedish orange capsule. The subjects will be administered three (3) capsules of Targretin™ (75 mg/capsule) on a twice daily basis (450 mg/day) for five days.

Also known as: Targretin®
Bexarotene
PlaceboDRUG

The subjects will be administered three (3) capsules of Avicel PH on a twice daily basis (450 mg/day) for five days.

Also known as: Avicel PH
Placebo

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young healthy adults (age 21-50)
  • APOE3/3 genotype

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Compass Research

Orlando, Florida, 32806, United States

Location

Related Publications (1)

  • 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.

    PMID: 29067298DERIVED

MeSH Terms

Conditions

Alzheimer DiseasePlaque, Amyloid

Interventions

Bexarotene

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Craig T Curtis, MD

    Compass Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2014

First Posted

February 13, 2014

Study Start

August 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

US(1)