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


Phase 2
50 Years
90 Years
Open (Enrolling)
Both
Alzheimer's Disease

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Trial Information

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


Inclusion Criteria:



- Males or females 50 to 90 of age inclusive.

- Diagnosis of probable AD according to National Institute of Neurological and
Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders
Association (NINCDS-ADRDA) criteria.

- Willing and able to provide informed consent by either the subject or subject's legal
representative.

- Willing and able to comply with study visits, treatment plan, laboratory tests, brain
imaging and other procedures.

- Subjects must have a positive 18f-AV-45 PET scan as determined by a qualified rater.

- Mini-Mental State Examinations (MMSE) score between 10-20 inclusive.

- Must have a study partner who is able and willing to comply with all required study
procedures.

- Females must be postmenopausal.

- Have at least eight years of education and should have previously (in pre-AD
condition) been capable of reading, writing, and communicating effectively with
others in English.

- If receiving therapy with a cholinesterase inhibitor and/or memantine, the dose of
these agents has been stable for at least 4 weeks prior to randomization

- Normal laboratory findings at baseline including CBC, chemistry panel, serum lipids,
liver functions, TSH, and vitamin B12.

- Must consent to ApoE genotyping

Exclusion Criteria:

- Any clinically relevant neurological disorder capable of producing a dementia
syndrome including Parkinson's disease, stroke, vascular dementia, dementia with Lewy
bodies, frontotemporal dementia and others.

- 4 or more micro-hemorrhages (amyloid-related imaging abnormalities - hemorrhage type
(ARIA-H) on baseline MRI or any evidence of amyloid-related imaging abnormalities -
effusion type (ARIA-E) (Sperling et al, 2011).

- History of malignancy within the past five years with the exception of basal cell or
squamous cell cancer, in-situ cervical cancer, or localized prostate cancer.

- History of seizure in the past three years prior to randomization

- Any contraindication of having brain MRI

- Any contraindication of having PET (inability to lie flat and still for the duration
of the scan, intolerance to previous PET such as hypersensitivity reaction to PET
ligand or imaging agent)

- The subject has any unstable medical illness including hypertension, congestive heart
failure, chronic obstructive pulmonary disease, renal failure, liver failure or other
organ compromise.

- Other clinically important abnormality on vital signs, physical examination,
neurologic examination, laboratory results, or electrocardiogram (ECG) examination
(e.g. Atrial fibrillation) that could compromise the study or be detrimental to the
subject.

- The subject has received bexarotene previously.

- The subject has an allergy to bexarotene.

- Has had a PET scan in the past 12 months.

- Has had radiotherapy in the past year.

- Have participated in an investigational drug or device study within 30 days prior to
Visit 2.

- Have been treated with immunomodulators to treat AD (vaccines, antibodies etc) within
6 months prior to visit 2

- Unable to swallow uncrushed oral medication in capsule form

- Have any condition or reason that, in the opinion of the investigator, which could
interfere with the ability of the patients to participate or complete the trials, or
places the patient at undue risk or complicates the interpretation of safety or
efficacy data.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Standard uptake units regional (SUVR) on amyloid brain imaging obtained through 18F-AV-45 PET

Outcome Description:

The primary study endpoint is the change from baseline to Week 4 in amyloid burden as measured by standard uptake units regional (SUVR) on amyloid brain imaging obtained through 18F-AV-45 PET

Outcome Time Frame:

Week 4

Safety Issue:

No

Principal Investigator

Jeffrey L Cummings, MD, ScD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Institutional Review Board

Study ID:

CCF-IRB 12-783

NCT ID:

NCT01782742

Start Date:

February 2013

Completion Date:

March 2014

Related Keywords:

  • Alzheimer's Disease
  • Mild to Moderate Alzheimer's Disease
  • Alzheimer Disease

Name

Location

Cleveland Clinic Lou Ruvo Center for Brain HealthLas Vegas, Nevada  89106