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PREPARE
Alzheimer's Disease Prevention Trial. A Multi-Center, Randomized, Double-Blind Placebo Controlled Trial of Estrogens to Prevent Alzheimer's Disease and Loss of Memory in Women.
| Status: | Active, Not Recruiting |
| Eligible Population(s): | Normal Controls |
| GCO Number: | |
| Principal Investigator: | Mary Sano, PhD |
| Study Coordinator: | Rachel Shiovitz |
PREPARE stands for: PREventing Postmenopausal Memory Loss and Alzheimer’s with Replacement Estrogens
PREPARE is a five year study to determine if estrogens used over a period of 3 years can prevent memory loss and Alzheimer’s disease in women with a family history of Alzheimer’s disease.
PREPARE is a double-blind placebo controlled clinical trial. The effect of estrogens will be compared to a placebo (sugar pill) to determine if the effect is real. In a double blind study neither the participant nor the investigator knows who is getting the active medication and who is not. This helps to insure that the observed effect is due to the treatment and not to other extraneous factors.
At the present time, this study is closed to enrollment. No more participants are being recruited for this study. The participants involved in the study are being followed observationally through the term of the study. All participants are off study medication.
Updates of the study will be disclosed in writing to the Principal Investigators at participating sites and to the participants via letters. The public will be informed via publications and on this web site.
Women with a family history of Alzheimer’s disease are at higher risk of getting the disease and therefore fewer participants are needed to determine if this drug will work. Those with an afflicted family member often have a very high motivation to learn more about the disease.
Estrogens may increase the growth of cells in the lining of the uterus. To protect against this women who have a uterus will receive progesterone, which eliminates this possible side-effect of estrogen. Some studies have suggested that estrogen may increase the risk of blood clotting, particularly in women who have a history of blood clots. A careful medical history is taken at the start of the study to insure that this problem has not occurred in the past. Women who do have this history will not be included. Some studies suggest that estrogen may increase the risk of breast cancer particularly after extended use of 10 years or more. Recent studies have suggested that the type of cancer associated with estrogen use is highly treatable and has an overall good outcome. This study has a much shorter exposure to estrogen (3 to 4 years). Nevertheless, women who have had breast cancer were not included in the study. In addition, participants will have yearly mammograms and breast examinations which are likely to detect even the slightest changes.
This study is closed to recruitment.