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Open Label Study of Isotretinoin in Mild to Moderate Alzheimer's Disease

Information source: University Hospital Case Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Disease

Intervention: Isotretinoin (Drug)

Phase: Phase 1/Phase 2

Status: Terminated

Sponsored by: University Hospital Case Medical Center

Official(s) and/or principal investigator(s):
Alan J Lerner, MD, Principal Investigator, Affiliation: University Hospital Case Medical Center

Summary

This is an open label study of isotretinoin, a medication which is FDA approved for treatment of other conditions to determine initial safety in Alzheimer's disease.

Clinical Details

Official title: Open Label Study of Isotretinoin in Mild to Moderate Alzheimer's Disease

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from Baseline to Six month timepoint in the score on the Alzheimer's disease Assessment Scale- Cognitive subscale

Secondary outcome: Number and types of adverse effects

Eligibility

Minimum age: 50 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Probable AD by DSM IV and NINCDS-ADRDA criteria

- Females must be surgically sterile (bilateral tubal ligation, both ovaries removed or

hysterectomy) or post-menopausal for at least 2 years.

- > 50 years of age

- Residing in the community at baseline (includes assisted living facilities, long-term

care nursing facilities)

- Mini Mental State Examination at screen of 12-26 (inclusive)

- No medical contraindications to study participation

- Fluent in English at least 8 years of education.

- Supervision available for study medication. Caregiver/study partner to accompany

participant to all visits. Study partner must have direct contact with the participant > 2 days/week

- Able to ingest oral medication.

- Neuroimaging (CT or MRI or PET) consistent with the diagnosis of AD at some time

after the onset of the memory decline.

- Clinical laboratory values must be within normal limits or, if abnormal, must be

judged to be clinically insignificant by the investigator

- Stable use of cholinesterase inhibitors and memantine is permitted if doses are

stable for 3 months prior to enrollment. Dose should be stable throughout the study unless it is clinically necessary to adjust the medication.

- Stable use of anti-depressants is permitted if doses are stable for 3 months prior to

enrollment. Dose should be stable throughout the study unless it is clinically necessary to adjust the medication. Exclusion Criteria:

- Dementia not due to probable Alzheimer's disease

- Pregnancy, breastfeeding. The rationale is that retinoids are teratogenic and are

excreted in breast milk.

- History of clinically significant stroke

- Modified Hachinski Ischemia score ≥ 4

- Current evidence or history in past two years of epilepsy, seizure, focal brain

lesion, head injury with loss of consciousness or DSM IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, severe alcohol or substance abuse.

- Sensory impairment which would prevent subject from participating in or cooperating

with the protocol.

- Use of another investigational agent within two months.

- Evidence of any significant clinical disorder or laboratory finding that renders the

participant unsuitable for receiving an investigational new drug including clinically significant or unstable hematologic, hepatic, cardiovascular (including history of ventricular fibrillation or ventricular tachycardia), pulmonary, gastrointestinal, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality. Abnormal liver function test, including AST, ALT, total bilirubin, or prothrombin time. The rationale is that retinoids can be hepatotoxic.

- Participants receiving behavioral medications (including antidepressants,

antipsychotics and anxiolytics) must be on stable doses for at least 4 weeks prior to randomization.

- Active neoplastic disease and any medical conditions requiring concurrent

immunosuppression.

- Hypertriglyceridemia greater than 500 mg/dL despite statin/fibrate therapy. The

rationale is that retinoids can increase lipids, particularly triglyceride and this can lead to pancreatitis.

- Any medical conditions requiring concurrent use of tetracycline, minocycline, or

doxycycline. The rationale is due to enhanced risk of increased intracranial pressure.

- Hypersensitivity to retinoids.

- Presence of psychosis or hallucinations at baseline as determined by Neuropsychiatric

inventory or Geriatric Depression Scale-short form greater than or equal to five

- Presence of any unstable cardiovascular disease, uncontrolled diabetes, chronic

inflammatory or infectious conditions. Retinoids have been associated with chest pain of unclear etiology, increased serum glucose, myelosuppression and increased risk of infection.

- Use of Drugs and supplements such as: Vitamin A supplements beyond 100% RDA, other

immunosuppressants (corticosteroids, chemotherapeutic agents, etc.), Warfarin , Fish Oil (DHA)

- Any other disease or medical or psychiatric condition or laboratory abnormality that

may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this clinical trial.

Locations and Contacts

Parkway Medical Building, Beachwood, Ohio 44122, United States
Additional Information

University Hospitals Case Medical Center

Related publications:

Lee HP, Casadesus G, Zhu X, Lee HG, Perry G, Smith MA, Gustaw-Rothenberg K, Lerner A. All-trans retinoic acid as a novel therapeutic strategy for Alzheimer's disease. Expert Rev Neurother. 2009 Nov;9(11):1615-21. doi: 10.1586/ern.09.86. Review.

Starting date: April 2012
Last updated: August 27, 2014

Page last updated: August 23, 2015

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