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CompletedPhase 2 / PHASE3

Alzheimer's Disease: Therapeutic Potential of Estrogen

Lead sponsor

University of Wisconsin, Madison

Assets

Estradiol / Medroxyprogesterone

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 55-90•Female

Primary endpoint

•Cognition

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 ID2001-477

SecondaryFDA IRB approval M1285

Secondary IDIA0048Study Team

NCT IDNCT00066157

SecondaryNIH grant AG17196-03

NihR01AG017196-03

Timeline

Milestones

Study start2001-09 (month precision)

Study first posted2003-08-05estimated

Primary completion2007-12actual (month precision)

Study completion2007-12actual (month precision)

Last update posted2018-08-23actual

Assets

Drug assets

Estradiol Medroxyprogesterone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age90 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•Postmenopausal women with Alzheimer's disease and without other dementias (diagnosed by study staff or from an outside clinic)

•Mini Mental State Examination score greater than 15/30

Exclusion criteria

•History of cancer of reproductive tissues

•History of deep vein thrombosis or blot clots

•Diabetes

•Heart disease or stroke

•Liver problems including hepatitis

•Severe vision or hearing problems

•Tobacco use

•Lack of an adequate caregiver

•inability to perform psychometric testing

Endpoints (3)

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

Other (unclassified)

Memory

1 endpoint

Primary/protocol endpoint

Cognition: delayed recall on Buschke Selective Reminding Test; Stroop Interference condition--completion time and errors; Clinician-rated Interview Based Impression of Change

Time frame:Baseline and 1, 3, 6, 12, and 15 months

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Skills of Independent Living: Physical functioning Performance (PFP)

Time frame:Baseline and 1, 3, 6, 12, and 15 months

descriptive

Secondary/protocol endpoint/low confidence

Bioassays (Estradiol, estrone, medroxyprogesterone, FSH, influence of ApoE genotype in responsivity to estrogen)

Time frame:Baseline and 1, 3, 6, 12, and 15 months

descriptive

Publications (3)

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.