Facts About a Study of Estrogen and
Alzheimer's Disease

What is estrogen?

Estrogen is a hormone 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. Estrogen also has been found to have many beneficial effects on brain cells.

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

Recent research shows that estrogen has a beneficial effect on brain cells and chemicals. Brain cells form better connections in the presence of estrogen. The enzyme that forms the neurotransmitter acetylcholine is promoted in the presence of estrogen. Several small clinical studies have demonstrated that estrogen may improve cognitive function and mood measures in women with Alzheimer's disease.

Who is eligible to participate?

A person may be eligible to participate if they:

• are female 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
• have no history of cancer of the reproductive system (breast, ovary, uterus)
• are in stable general health and 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 study center. A consent form will also be provided.

What is involved for persons who wish to participate 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 neurological examination as well as blood and urine tests, pelvic and breast examination, mammogram and pap smear. Optional studies include a spinal tap and blood analysis for genetic testing.

Once accepted into the study, the participants will make 6 outpatient clinic visits over a 64 week period. These visits include a brief physical exam, a blood test, and tests of memory and behavior

What is the treatment plan and study design?

Patients who meet the eligibility requirements and decide to participate in the study will be randomly assigned to receive 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 and who is receiving placebo. This type of study is called a randomized placebo controlled, double-blind study design.

Where can I get more information?

To determine if your family member is eligible to participate in this study, contact the study center in your area

Where will the studies take place?

AL

Birmingham: University of Alabama
Penny Forsyth LVN (205) 934-1668

CA

Irvine: University of California, Irvine
Catherine Ortiz BSN (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 South Florida
Dottie Baxter (813) 974-4355

GA

Atlanta: Emory University
Cheryl Bissey-Black RN (404) 728-6453

IL

Chicago: Rush Presbyterian-St. Luke's Medical Center
Amy Levin RN (312) 942-4463

Springfield: Southern Illinois University
Sandra Vicari PhD (217)785-3837

IN

Indianapolis: Indiana University Medical Center
Sharon Weitlauf RN BSN (317) 274-1351

KY

Lexington: University of Kentucky
Elizabeth Bacon (606) 257-8356

MA

Boston: Massachusetts General Hospital
Marsha Tennis RN (617) 726-1610

MD

Baltimore: Johns Hopkins University
Lisa Resau RN (410) 550-2599

MN

Minneapolis: University of Minnesota
Margaret Prod Homme (612) 624-1404

Rochester: Mayo Clinic
Kris Johnson RN (507) 284-4006

MO

Kansas City: University of Kansas Medical Center
Michael White RN (913) 588-6976

St. Louis: Washington University
Mary Coats RN (314) 28602303

NY

Bronx: Mount Sinai School of Medicine
Theresa Ryan (718) 584-9000 ext. 5198

New York: Columbia-Presbyterian Medical Center
Arlene Lawton (212) 305-9194

New York: New York University Medical Center
Malca Resnick (212) 263-5708

White Plains: Burke Medical Research Institute
Judith Sandorf (914) 948-0050 ext. 2307

OH

Cleveland: University Hospitals of Cleveland
Nancy Strick (216) 844-8202

PA

Philadelphia: University of Pennsylvania
Geri Emling (215) 662-7810 ext. 4376 or 4377

Pittsburgh: University of Pittsburgh
Lori Macedonia (412) 647-2160

TX

Dallas: University of Texas - SW Medical Center
Doris Svetlik (214) 648-3198

Houston: Baylor University
Lisa Lipscomb RN (713) 789-7431

WA

Seattle: University of Washington
Polly Amkraut (206) 68509169

Who is sponsoring this study?

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

This fact sheet is provided for your information only, and does not represent an endorsement of estrogen therapy by the Alzheimer's Association.

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