Alzheimer's Disease: Therapeutic Potential of Estrogen

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a 15-month study to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Alzheimer's Disease and Aging: Therapeutic Potential of Estrogen

NCT00018343

Alzheimer's Disease

COMPLETED PHASE2

Alzheimer's Disease Prevention Trial

NCT00000176

Alzheimer Disease Memory Disorders

COMPLETED PHASE3

Effects of Estrogen on Memory in Post-Menopausal Women and Patients With Alzheimer's Disease

NCT00006399

Alzheimer Disease

COMPLETED PHASE2

Aging and Estrogen on Cortical Function

NCT01268046

Memory Loss Cognitive Changes Postmenopausal Symptoms

COMPLETED PHASE1/PHASE2

Estrogen Modulation of Mood and Cognition Following Monoaminergic Depletion in Post-Menopausal Women

NCT00005768

Menopause

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Estrogen is a naturally occurring hormone produced in a woman's body. The purpose of this 15-month study is to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease and without other dementias.

Patients who volunteer for this study will either receive a patch containing 17-ß-estradiol or will receive an inactive placebo patch. In addition, patients will be given either medroxyprogesterone or an inactive placebo pill. Neither the volunteers nor the study staff will know which type of patch or pill a patient receives. Patients must be generally healthy and have mild-to-moderate dementia. There must be a patient caregiver who can watch for side effects and ensure that the patient takes the study medications on schedule. Patients will undergo neuropsychological tests and an evaluation of the ability to live independently at each visit as well as laboratory evaluations, such as the taking of blood. Each visit will last approximately 3 hours. A total of 160 participants are being recruited.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

estradiol patch and medroxyprogesterone

Group Type EXPERIMENTAL

Transdermal estradiol

Intervention Type DRUG

50 micrograms (low-dose) or 100 micrograms (high-dose) transdermal 17-ß-estradiol patch, changed every 3 days, for 12 months

Medroxyprogesterone

Intervention Type DRUG

2.5mg tablet daily for 12 months

2

estradiol patch and placebo pill

Group Type ACTIVE_COMPARATOR

Transdermal estradiol

Intervention Type DRUG

50 micrograms (low-dose) or 100 micrograms (high-dose) transdermal 17-ß-estradiol patch, changed every 3 days, for 12 months

Placebo

Intervention Type DRUG

Placebo tablet daily for 12 months

3

placebo patch and medroxyprogesterone

Group Type ACTIVE_COMPARATOR

Medroxyprogesterone

Intervention Type DRUG

2.5mg tablet daily for 12 months

Placebo Patch

Intervention Type DRUG

Transdermal placebo patch, changed every 3 days, for 12 months

4

placebo patch and placebo pill

Group Type PLACEBO_COMPARATOR

Placebo Patch

Intervention Type DRUG

Transdermal placebo patch, changed every 3 days, for 12 months

Placebo

Intervention Type DRUG

Placebo tablet daily for 12 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transdermal estradiol

50 micrograms (low-dose) or 100 micrograms (high-dose) transdermal 17-ß-estradiol patch, changed every 3 days, for 12 months

Intervention Type DRUG

Medroxyprogesterone

2.5mg tablet daily for 12 months

Intervention Type DRUG

Placebo Patch

Transdermal placebo patch, changed every 3 days, for 12 months

Intervention Type DRUG

Placebo

Placebo tablet daily for 12 months

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

17 (beta) estradiol transdermal patch Estrogen replacement therapy progesterone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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

Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No