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AlzRisk Paper Detail

Reference: Shumaker, 2004
Cohort: Women's Health Initiative Memory Study
Risk Factor: Hormone Therapy

Average Follow-up Time Detail
The average follow-up time was 5.2 years. The trial was conducted from June 1995 to February 29, 2004.

The estrogen plus progestin trial of the WHI ended in July 2002 due to significantly more noncognitive adverse events associated with conjugated equine estrogen (CEE) plus medroxyprogesterone acetate (MPA) compared with placebo. The WHI estrogen-alone trial concluded in February 2004 because the NIH considered excess stroke risk in the active hormone group to be unacceptable.

Exposure Detail
The intervention was 1 daily tablet containing either 0.625 mg/d of CEE or placebo.

Ethnicity Detail
In the estrogen-alone trial, 83% of participants were white. In the estrogren plus progestin trial, 90 % or participants were white.

Age Detail
The age provided is the average age of the women at baseline, calculated using a weighted average of the median of the reported age categories.

Screening and Diagnosis Detail
Screening Method:
"Modified" 3MSE"Modified" Modified Mini-Mental State Examination (Tschantz 2002)
CERADConsortium to Establish a Registry for Alzheimer's Disease (Morris 1989)
Informant interview
Neuropsych Testing

AD Diagnosis:
DSM IV Diagnostic and Statistical Manual IV

Total dementia definition: DSM-IV.

Screening: "In phase 1, participants underwent a cognitive screening with the Modified Mini-Mental State Examination (3MSE) [23] at baseline and annually thereafter. Women who scored below an education-adjusted cut point on the 3MSE (72 for those with 8 years of formal education and 76 for those with 9 years of education; to increase sensitivity, after 16 months new cut points of 80 for those with 8 years of education and 88 for those with 9 years of education were implemented prospectively [24]) underwent phase 2 of the WHIMS, including a modified Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) battery of neuropsychological tests [25] and standardized interviews to assess acquired cognitive and behavioral impairments [26,27]. In addition, a designated informant (friend or family member) was interviewed separately regarding acquired cognitive and behavioral impairments in the participant."

"After completing phase 2, participants were evaluated by a local physician-specialist with experience in diagnosing dementia (phase 3). Using a standardized protocol provided by the WHIMS CCC, local physicians reviewed all available data and performed a clinical neuropsychiatric evaluation. The physician then classified the WHIMS participant as having no dementia, MCI, or probable dementia, based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria [28]."

"Women suspected of having probable dementia underwent phase 4, including a non-contrast computed tomography brain scan and laboratory blood tests to rule out possible reversible causes of cognitive decline. If dementia was still suspected, the physician was required to provide the most probable etiology based on DSM-IV criteria for AD, vascular dementia (VaD), and other dementia-related classifications."

Covariates & Analysis Detail
Analysis Type:
Cox proportional hazards regression

Hazard ratios for Alzheimer's disease were not provided in the paper. We derived incidence rate ratios by using available data on Alzheimer's disease (number of cases, number of non-cases, person-time).