2021 Annual Progress Report
The WHI Memory Study (WHIMS; AS39) was an ancillary study to the WHI Hormone Trials and enrolled 7,427 women aged 65 years and older. WHIMS investigated the effects of hormone therapy on risk of probable dementia and any cognitive impairment and on changes in global cognition over time. Form 39 (Modified Mini Mental State Exam) was administered annually to WHIMS participants. If a participant scored at or below the cut point (80 for women with 8 or fewer years of formal education and 88 for those with 9 or more years of formal education), she progressed to further cognitive testing and clinical assessment. Note that before July 1, 1998 the cut points were 72 and 76. A friend or family member, whose name the participant furnished at the beginning of the trial, was also interviewed regarding her cognitive and behavioral status. Based on clinician judgment, some participants received additional medical tests (brain imaging and blood assay). All data were reviewed by a central adjudication committee who classified participants as: probable Dementia, Mild Cognitive Impairment or No Cognitive Impairment.
The original WHIMS study periods during the WHI Hormone Trials were 1995 until July 8, 2002 for the estrogen-plus-progestin trial, and 1995 through February 29, 2004 for the estrogen-alone trial. WHIMS was further extended (AS233, including 5,835 of the original WHIMS participants) until 2007, during which the study protocol was administered once annually to participants.
SCAP was instituted in 2005 to identify cases of Probable Dementia (PD) and Mild Cognitive Impairment (MCI), in the deceased and proxy-dependent participants. SCAP includes the Dementia Questionnaire (DQ), a standardized, validated instrument used to reliably classify dementia in deceased persons. It has demonstrated sensitivity and specificity. The DQ consists of 48 items assessing memory and other cognitive functions, language, daily functioning, insight, and other medical and psychiatric difficulties. The DQ is a semi-structured interview that was administered by telephone to informants previously selected by the participant, who are knowledgeable about the participant’s medical history and ante-mortem functional status. SCAP data are submitted to the central adjudication panel for classification similar to WHIMS. SCAP is ongoing.
Between April, 2005 and January, 2006, 1,426 women underwent magnetic resonance imaging (MRI) across 14 Women’s Health Initiative (WHI) centers. The effort yielded N=1,365 scans that met central reading center quality control standards. The WHIMS-MRI-2 protocol was designed to collect a second MRI (approximately 4 years after the first MRI) from these women to assess incident neuropathology and the rate of atrophy (N=730).
The WHI Study of Cognitive Aging (WHISCA) enrolled 2,302 WHIMS participants aged 66 to 84 years on average 3 years after WHI randomization and investigated the efficacy of postmenopausal hormone therapy on age related changes in specific cognitive functions in non-demented women at 14 of the 39 WHIMS sites. WHISCA provides more comprehensive annual assessments of cognitive function and mood. Annual follow-up of the WHISCA women continued after the termination of the WHI trials until 2010.
Women who were previously enrolled in the WHIMS Extension were recruited for WHIMS ECHO beginning in 2008. Instead of face-to-face evaluation, participants underwent an annual centralized, validated cognitive telephone interview for tracking changes in cognitive status (Rapp et al., 2012). The interview is comprised of a neuropsychological battery including a global cognitive screener (modified Telephone Interview for Cognitive Status, known as the TICSm) and additional neuropsychological tests. A score <30 triggers the collection of the Dementia Questionnaire from the proxy. As in WHIMS, all information is submitted to the central adjudication panel for classification (Dementia, MCI, No Impairment).
The Women’s Health Initiative Memory Study of Younger Women (WHIMS-Y) aims to assess the long-term impact of random assignment to postmenopausal hormone therapy among women who were aged 50-54 at the time of randomization into the WHI hormone trials. Secondary objectives relate to the consistency of any treatment effects across unopposed or opposed therapy and whether there exists evidence of graded relationships between cognitive effects and age of administration, years from menopause, and baseline risk factors for cognitive impairment. Assessment procedures identical to those in WHIMS-ECHO were used with central adjudication of impairment.
Prior to downloading or using WHIMS data, please carefully review the related dataset documentation.
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