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TerminatedPhase 1 / PHASE2Results posted

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

Asset

Isotretinoin

Listed sites

1

Recruiting sites

-

Enrollment

3

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-26

Primary endpoint

•The Score on the Alzheimer's Disease Assessment Scale- Cognitive Subscale

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDISOTRT-01
NCT IDNCT01560585

Timeline

Milestones

Study first posted2012-03-22estimated
Study start2012-04actual (month precision)
Primary completion2014-08actual (month precision)
Study completion2014-08actual (month precision)
Last update posted2022-06-15actual
Results first posted2022-06-15actual

Assets

Drug assets

Isotretinoin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
2
Safety / tolerability / PK
2

Global cognition

2 endpoints
Primary/protocol endpoint

Change From Baseline to Six Month Timepoint in the Score on the Alzheimer's Disease Assessment Scale- Cognitive Subscale

Time frame:6 months from baseline

change from baseline, improvement

Primary/registry result

Change From Baseline to Six Month Timepoint in the Score on the Alzheimer's Disease Assessment Scale- Cognitive Subscale

Time frame:6 months from baseline

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Number of Adverse Effects

Time frame:28 weeks

event count, event

Secondary/registry result

Number of Adverse Effects

Time frame:28 weeks

event count, event

Posted result

GroupValue (number), Number of eventsReported bounds
Open Labeln=3 Participants2-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.