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Open Label Study of Isotretinoin in Mild to Moderate Alzheimer's Disease | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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

NCT01560585•University Hospitals Cleveland 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.

Detailed Description

Retinoids have some relevant characteristics that could be considered useful in treating AlZheimer's disease. These include anti-inflammatory properties, possible anti-amyloid formation proeprties and inhibition of cell cycle properties

Eligibility

Age

50 - 90 years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

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.
+7 more criteria

Locations (1)

Parkway Medical Building

Beachwood, Ohio, United States

Key Dates

Start Date

April 1, 2012

Primary Completion Date

August 1, 2014

Completion Date

August 1, 2014

Last Updated

June 15, 2022

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

Isotretinoin

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

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