Open Label Study of Isotretinoin in Mild to Moderate Alzheimer's Disease (NCT01560585) | Clinical Trial Compass
TerminatedPhase 1/2
Open Label Study of Isotretinoin in Mild to Moderate Alzheimer's Disease
Stopped: Adverse events in 2/3 participants; study was halted but not restarted after this due to insufficnet funds as well
United States3 participantsStarted 2012-04
Plain-language 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.
Who can participate
Age range50 Years – 90 Years
SexALL
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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
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What they're measuring
1
Change From Baseline to Six Month Timepoint in the Score on the Alzheimer's Disease Assessment Scale- Cognitive Subscale
Timeframe: 6 months from baseline
Trial details
NCT IDNCT01560585
SponsorUniversity Hospitals Cleveland Medical Center