Alzheimer's Association Statement on Combination Hormone Therapy and Increased Risk for Dementia

Alzheimer's Association
Tuesday, 27 May 2003

The Alzheimer's Association intends the following information to help clarify the recent research findings linking combination hormone replacement therapy to an increased risk of dementia including Alzheimer's disease. The research, part of the Women's Health Initiative Memory Study (WHIMS) and reported in the current issue of JAMA, found increased risk of developing dementia in a study of women 65 and older taking PremproTM, a form of estrogen plus progestin hormone therapy.

Marilyn Albert, Ph.D.
Professor of Neurology
Johns Hopkins University School of Medicine
Chair, Alzheimer's Association Medical and Scientific Advisory Council

"This clinical trial was prompted by a wide range of observational and laboratory data that suggested HRT reduced women's risk of developing dementia including Alzheimer's. No one anticipated this outcome. This news underscores the important role that clinical trials play in determining whether data from observational studies are valid. The report shows us again that the 'gold standard' for evidence is a double-blind, randomized clinical trial designed specifically to test the effects of a treatment.

"While the study clearly shows an increase in risk for dementia, the actual risk for each individual is very small. Age remains the single greatest risk factor for dementia. Risk of developing dementia doubles every five years after age 65. To put the increased risk observed in
the WHIMS study into perspective, a 65-year-old woman on estrogen plus progestin therapy would have the increased risk profile of a 70-year-old woman not taking HRT.

"This clinical trial was on the effects of estrogen plus progestin therapy. It is possible that the increased risk is specific to the combination therapy or even the progestin. As part of the Women's Health Initiative, further investigation on estrogen therapy alone in women with a prior hysterectomy continues. This study is being carefully followed by the Data Safety Monitoring Board, which has observed no evidence of harmful effects.

"The Alzheimer's Association supports the National Institute on Aging (NIA) recommendation that older, post-menopausal women not take hormone replacement therapy involving a combination of estrogen plus progestin to prevent or reduce risk of dementia. Women with symptoms of menopause should discuss the relative benefits and risks of hormone replacement therapy as treatment for these conditions in consultation with their doctors. This complex treatment decision should be based on a thoughtful evaluation of how the known risks and benefits relate to all aspects of a particular woman's well being, including current health, symptoms and family history.

"The Alzheimer's Association is committed to re-doubling its commitment to research, funded by the association and by the federal government, to ensure that all possible preventions and treatments for Alzheimer's disease are both safe and effective."

For more information, or to contact Alzheimer's Association, see their website at: www.alz.org