AS39 - The effects of HRT on the development and progression of dementia (WHIMS)

Investigator Names and Contact Information

Sally Shumaker (sshumake@wakehealth.edu)

Introduction/Intent

WHI Memory Study (WHIMS) Data Overview

The WHIMS datasets include baseline and follow-up data collected through December 31, 2017. Data dictionaries for additional variables will be added as they become available. WHI PIs may download these datasets. Others who need access should ​go through their PI.

Everyone who will be using WHIMS data must return a signed copy of the data use agreement to the WHI Helpdesk. If you have questions about gaining access or downloading data, please direct them to the WHI Helpdesk.

We strongly advise you to read the data preparation documents before beginning your analysis. The zipped dataset file includes: SAS data set (.sas7bdat), Data dictionary (.pdf), and Data preparation (.pdf).

WHI Memory Study (WHIMS): Overview of Program Components

1. On Trial (WHI Study #AS39, WHIMS)

   1995 - July 8, 2002 for CEE+MPA trial; 1995 through February 29, 2004 for CEE-alone trial

   N=7,427

   WHIMS was an ancillary study to the WHI Hormone Trials and enrolled approximately 7,500 women aged 65 years and older. WHIMS investigated the effects of hormone supplementation 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.

2. Post-Trial Extension (WHI Study #AS233; WHIMS Extension)

   End-date of trial - September 30, 2007

   N~5,835

   During the post-trial/extension period, the WHIMS protocol continued to be administered annually to WHIMS participants through 2007.

3. Supplemental Case Ascertainment Protocol (SCAP; Subset of AS233, WHIMS Extension)

   2005 - Present

   N~1,025

   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.

4. Magnetic Resonance Imaging (MRI-1 and -2; WHI Study #AS183, WHIMS MRI)

2004 - 2010

N=1,365

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).

5. WHI Study of Cognitive Aging (WHISCA; WHI Study #AS103)

1999 - 2010

N~2,302

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.

6. WHI Epidemiology of Cognitive Health Outcomes (ECHO; WHI Study #AS244, WHIMS ECHO)

2008 – 2021

N~2,900

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).

7. WHIMS-Y (WHI Memory Study of Younger Women; WHI Study #AS262)

   2009 – 2016

   N~1,000

   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.