Estrogen Replacement Therapy for Treatment of Mild to Moderate Alzheimer Disease.Mulnard RA, Cotman CW, Kawas C, et al (University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). , Irvine, Irvine, Calif; Johns Hopkins University Johns Hopkins University, mainly at Baltimore, Md. Johns Hopkins in 1867 had a group of his associates incorporated as the trustees of a university and a hospital, endowing each with $3.5 million. Daniel C. , Baltimore, Md), JAMA JAMA abbr. Journal of the American Medical Association . 2000;283: 1007-1015. Estrogen decline has been implicated in the development and progression of Alzheimer disease (AD) in women. The purpose of this study was to determine if women with AD who were treated with estrogen would demonstrate improvements or stability in cognitive function over 12 months. The authors' secondary purposes were to determine what other psychological components might be influenced by treatment, to test 2 different doses of estrogen, and to determine the safety of using estrogen with women with AD. A double-blind, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , placebo controlled trial was designed for women with mild to moderate AD. Participants were recruited from 32 sites of the Alzheimer's Disease Cooperative Study (ADCS ADCS Alzheimer's Disease Cooperative Study ADCS Automated Data Capture System ADCS Attitude Determination and Control System ADCS Attitude Determination and Control Subsystem ADCS Assistant Deputy Chief of Staff ADCS Army Dental Care System ). A total of 120 women with hysterectomies qualified for the study over a 4-year period. Participants were included if they (1) had a diagnosis of mild to moderate AD based on National Institute of Neurological and Communicative Association criteria and Mini-Mental Status Examination (MMSE MMSE Mini Mental State Examination MMSE Minimum Mean Squared Error MMSE Mini-Mental Status Examination MMSE Multiuse Mission Support Equipment MMSE Multimission Support Equipment MMSE Multi Media Service Environment ) results, (2) were older than 60 years, and (3) had no other depressive or medical disorders. The primary outcome measure was the ADCS version of the Clinical Global Impression of Change Scale (CGIC). The MMSE and Clinical Dementia Rating The Clinical Dementia Rating or CDR is a numeric scale used to quantify the severity of symptoms of dementia (i.e. its 'stage'). Using a structured-interview protocol developed by John C. Scale (CDR (1) See CD-R and extension. (2) (Call Detail Reporting) See call accounting. (3) (Common Data Rate) A standard sampling rate for digital video for 480i and 576i systems. The rate is 13.5 MHz. See ITU-R BT. ) were used as global measures of the stage of Alzheimer disease. The secondary measures included measures of depression and mood state, verbal learning and mood-congruent memory. In this 12-month study, participants were enrolled and randomized into 1 of 3 groups: placebo, low-dose Premarin, or high-dose Premarin. The dosing phase was followed by a 3-month placebo phase for all women. The placebos were identical to the Premarin pills and adherence was monitored at each visit. All outcome measures were evaluated at baseline and at 2, 6, 12, and 15 months. No significant differences were found between the groups at baseline. Logistic regression adjustments were used for outcome measures. A 2-group comparison, combining both estrogen groups for analysis with placebo, and a 3-group analysis were performed. In the 2-group analysis, there was no difference in the CGIC between groups in the percentage of patients whose disease progression worsened. There was a significant difference on the CDR, favoring the placebo group in both the 2- and 3-group analyses. There was no evidence of improvement in global function in any of the analyses. Secondary measures showed no significant differences between groups. The estrogen dose did not have a significant effect on any variable, and adverse effects were not different between groups. The authors concluded that use of estrogen did not improve cognitive outcomes in women with mild to moderate AD over a 1-year period. They stated that estrogen does not appear to have a role in treatment of existing AD and that additional research is needed to determine whether estrogen replacement is beneficial in delaying onset of the disease. Susan Scherer, PT, MA University of Colorado Health Sciences Center The University of Colorado Health Sciences Center (UCHSC) is part of the University of Colorado System. It has recently been merged with the University of Colorado at Denver (UCD) to form the University of Colorado at Denver and Health Sciences Center. Denver, Colo |
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