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UnknownPhase 2

Efficacy and Safety of Tamibarotene (OAM80) for Alzheimer's Disease

Asset

Tamibarotene

Listed sites

1

Recruiting sites

1

Enrollment

50

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 10-26•AD symptomatic therapy: stable

Primary endpoint

•Changes in Alzheimer's Disease Assessment Scale (ADAS-JCog)

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

NCT IDNCT01120002
Org study IDOAM80-01

Timeline

Milestones

Study start2010-05 (month precision)
Study first posted2010-05-10estimated
Last update posted2011-07-22estimated
Primary completion2012-12estimated (month precision)
Study completion2012-12estimated (month precision)

Assets

Drug assets

Tamibarotene

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Japanese patients who are diagnosed as probable Alzheimer' Disease according to NINCDS-ADRDA criteria
•Diagnosed by brain diagnostic imaging (CT, MRI) within six months before the consent and no occurrence of the event after that to suggest cerebral vascular disease
•Mild to Moderate Alzheimer's Disease of MMSE from 10 to 26
•Age from 55 to 80
•Treated for a minimum of 12 weeks with a stable dose of donepezil and willing to continue the same during the trial period
•For women Menopause ≥ 2 years
•For men contraceptive measures are required during the study and after 6 months
•In principle patients should be living at their home in the presence of a caregiver who is defined as a healthy person in contact with the patient for more than 10 hours a week, could provide required information of the behavior and activities of daily living, accompany all the clinical examination, and supervise the handling and administration of the drug throughout the study period.
•Patients who could take pills as a whole
•Patient, caregiver and patient surrogate are able and willing to comply with study visits and procedures per protocol, understand, sign, and date the written voluntary informed consent form

Exclusion criteria

•Any cause of dementia not due to Alzheimer's disease
•Past history of other central nervous condition or psychiatric disease
•Symptom of depression and drug addiction
•Impairment in the physical function by other factor than the Alzheimer's Disease
•Patients who are expected to move in to care facilities during the study period
•triglyceride > 400 mg/dL

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
1
Function / daily living
1
Caregiver / quality of life
1
Other (unclassified)
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Changes in Mini-Mental State Examination (MMSE)

Time frame:baseline, 12 weeks, 24 weeks

Mini-Mental State Examination (MMSE)

descriptive

Function / daily living

1 endpoint
Secondary/protocol endpoint

Changes in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

Time frame:baseline, 12 weeks, 24 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

Changes in Clinician Interview-Based Assessment of Change Plus Caregiver Information (CIBIC-Plus)

Time frame:baseline, 12 weeks, 24 weeks

descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Changes in Alzheimer's Disease Assessment Scale (ADAS-JCog)

Time frame:baseline, 12 weeks, 24 weeks

descriptive

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 tableno registry results posted yet

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.