Estrogen Protocol Information Sheet


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What is estrogen?

Estrogen is a hormone which is dominant in the female reproductive system. The majority of estrogen is produced by the ovaries of the female. Men also produce estrogen by converting testosterone into estrogen. This hormone has also been found to have many beneficial effects on the brain cells, which provides the basis for the use of estrogen to treat Alzheimer's disease.

Why is estrogen being tested in persons with Alzheimer's disease?

Recent research in both the basic science laboratory and the clinical setting has shown a beneficial effect of estrogen on brain cells and brain chemicals. Brain cells form better connections in the presence of estrogen. The enzyme which forms the neurotransmitter, acetylcholine, is promoted in the presence of estrogen. Several very small clinical studies have demonstrated improvement in cognitive function and mood measures in women with Alzheimer's disease.

How many patients will be studied?

Approximately 120 female patients will be enrolled at 26 university medical centers across the United States.

Who is eligible for participation?

A person may be eligible to participate if they:
  • are of female gender and older than 60 years of age
  • have a diagnosis of Alzheimer's disease
  • are not currently taking estrogen replacement therapy
  • have had a hysterectomy
  • are in stable general health (do not have any uncontrolled health problems, like untreated high blood pressure or thyroid disease)

All medical and eligibility requirements will be described in detail by the staff of a participating institution. A consent form will also be provided.

What is involved in participation in this study?

A person who is interested in participating should contact the nearest study center. If the person appears to meet the eligibility requirements, then an initial screening visit will be arranged. At the screening visit, the person will have a comprehensive physical and neuropsychological exam, along with some laboratory tests, including blood and urine tests, EKG, pelvic and breast exam, mammogram, and pap smear. Optional tests include a spinal tap and genetic testing. Once accepted into the study, the patient will make six outpatient clinic visits over a 64-week period with two followup visits, all of which include blood tests and tests of memory and behavior.

What is the study design?

Patients who meet the eligibility requirements and decide to participate in the study will be randomly assigned to either one of two doses of estrogen or a placebo (sugar pill). Neither the patients nor the participating investigators will know who is receiving the estrogen pills and who is receiving placebo pills. This type of study is called a randomized, placebo-controlled, double-blind study design.

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Where can I get more information?

To determine if your family member is eligible to participate in this study, please contact the study center in your area. See the attached list of participating centers.

For more information regarding the estrogen replacement study, please call the participating center nearest you:

AL

  • Birmingham

    • University of Alabama -- Penny Forsyth -- 205-934-1668

CA

  • Irvine

    • University of California, Irvine -- Catherine Ortiz -- 714-824-2382

  • San Diego

    • University of California, San Diego -- Deborah Fontaine -- 619-622-5806

FL

  • Jacksonville

    • Mayo Clinic-Jacksonville -- Francine Parfitt -- 904-953-7103

  • Tampa

    • University of Southern Florida, Suncoast -- Dottie Baxter -- 813-974-4355

GA

  • Atlanta

    • Emory University -- Cheryl Bissey-Black -- 404-728-6453

IL

  • Chicago

    • Rush Presbyterian-St. Luke's -- Amy Levin -- 312-942-4463

  • Springfield

    • Southern Illinois University -- Sandra Vicari -- 217-785-4468

IN

  • Indianapolis

    • Indiana University Medical Center -- Nicki Coleman -- 317-274-1351

KS

  • Kansas City

    • University of Kansas Medical Center -- Michael White -- 913-588-6976

KY

  • Lexington

    • University of Kentucky -- Jeff Howe -- 606-323-6040

MA

  • Boston

    • Massachusetts General Hospital -- Marsha Tennis -- 617-726-1610

MD

  • Baltimore

    This study is being conducted by the Alzheimer's Disease Cooperative Study Unit and is funded by the National Institutes of Health.

    Text provided by the Department of Cognitive Science and the Institute for Brain Aging and Dementia, University of California, Irvine, CA 92717-4540.

    June 11, 1996

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