Trial Outcomes & Findings for Open Label Study of Isotretinoin in Mild to Moderate Alzheimer's Disease (NCT NCT01560585)

Last Updated: 2022-06-15

Results Overview

Alzheimer's disease Assessment Scale- Cognitive subscale is a scale to measure cognitive function used in dementia clinical trials. No primary outcome data since study was terminated before any participaant completed

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

3 participants

Primary outcome timeframe

6 months from baseline

Results posted on

2022-06-15

Participant Flow

Recruited from clinical population of PI

Participant milestones

Participant milestones
Measure	Open Label All participants will receive Isotretinoin for 24 weeks Isotretinoin: Isotretinoin 0.5 mg per kilogram body weight (rounded to nearest 10 mg) per day for 24 weeks
Overall Study STARTED	3
Overall Study Screened	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Open Label All participants will receive Isotretinoin for 24 weeks Isotretinoin: Isotretinoin 0.5 mg per kilogram body weight (rounded to nearest 10 mg) per day for 24 weeks
Overall Study Physician Decision	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label n=3 Participants All participants will receive Isotretinoin for 24 weeks Isotretinoin: Isotretinoin 0.5 mg per kilogram body weight (rounded to nearest 10 mg) per day for 24 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants
impaired cognition due to alzheimer's disease diagnosis	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months from baseline

Population: Data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 weeks

Any adverse events reported by subject or study partner will be recorded at each visit after screening (Baseline, and visits at week 4, 8, 12, 16, 20, 24, and 28 (four weeks after treatment discontinuation).

Outcome measures

Outcome measures
Measure	Open Label Treatment n=3 Participants All participants will receive Isotretinoin for 24 weeks
Number of Adverse Effects	2 Number of events

Adverse Events

Open Label Treatment

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Open Label Treatment n=3 participants at risk Study terminated due to adverse events leading to PI decision to terminate study
Neoplasms benign, malignant and unspecified (incl cysts and polyps) neoplasm	33.3% 1/3 • Number of events 1

Other adverse events

Other adverse events
Measure	Open Label Treatment n=3 participants at risk Study terminated due to adverse events leading to PI decision to terminate study
Nervous system disorders loss of consciousness	33.3% 1/3 • Number of events 1

Additional Information

Alan J Lerner,MD

University Hospitals Cleveland Medical Center - Cleveland, OH

Phone: 1 216 464 6449

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place