Memory Study of Youngest Women Enrolled in the Women's Health Initiative Hormone Therapy (HT) Arm (WHIMS-Y)
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ClinicalTrials.gov Identifier: NCT01124773 |
Recruitment Status :
Completed
First Posted : May 17, 2010
Last Update Posted : November 6, 2017
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Condition or disease |
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Dementia |
Study Type : | Observational |
Actual Enrollment : | 1362 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Women's Health Initiative Memory Study of Younger Women |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | June 2016 |

Group/Cohort |
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Previous HT use and cognition
Women who were aged 50-54 at the time of randomization into the WHI hormone trials.
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- All-cause dementia and Mild Cognitive Impairment [ Time Frame: Measured once a year ]Participants will have a cognitive assessment administered over the telephone.
- Global and domain specific cognitive function. [ Time Frame: Measured once a year ]Participants will have a cognitive assessment administered over the telephone.

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Ages Eligible for Study: | 50 Years to 54 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Must be enrolled in the Women's Health Initiative Extension
Exclusion Criteria:
- Not enrolled in the Women's Health Initiative Extension

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01124773
United States, North Carolina | |
Wake Forest University Health Sciences | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Stephen R Rapp, PhD | Wake Forest University Health Sciences |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Wake Forest University Health Sciences |
ClinicalTrials.gov Identifier: | NCT01124773 |
Other Study ID Numbers: |
699 |
First Posted: | May 17, 2010 Key Record Dates |
Last Update Posted: | November 6, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | WHIMS-Y will follow guidelines, methods and processes as set forth in the WHI 2015-2020 Data Sharing Plan. Limited data sets will be archived on the WHIMS-Y website. Accompanying the limited data sets, substantial electronic documentation will be provided in a standard format that is readable on a variety of platforms. Documentation will include data collection forms, a description of study protocol and procedures, description of all variable re-coding and a list of major study publications. These data will be available to users only under a data-sharing agreement that provides for: a commitment to using the data only for research purposes and not to identify any individual participant; a commitment to securing the data using appropriate computer technology; and a commitment to destroying or returning the data after analyses are completed. Data will be made available for timely release no later than the acceptance for publication of the main findings from the final dataset. |
cognition memory hormone therapy |
Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurocognitive Disorders Mental Disorders |