This trial is active, not recruiting.

Condition dementia
Sponsor Wake Forest University Health Sciences
Start date August 2008
End date November 2021
Trial size 2922 participants
Trial identifier NCT00745056, 1436


The prevalence of illnesses associated with old age, including dementia, is rising significantly as the elderly population dramatically grows. The use of hormone therapy (HT) after menopause may increase the risk of dementia and cognitive decline, but more research is needed to confirm this link. This study will examine the incidence of dementia and cognitive decline in older women who participated in the Women's Health Initiative Memory Study (WHIMS), a study in which women received HT after menopause.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

All-cause dementia
time frame: Measured annually

Secondary Outcomes

Mild cognitive impairment
time frame: Measured annually

Eligibility Criteria

Female participants at least 65 years old.

Inclusion Criteria: - Participated in the WHIMS study Exclusion Criteria - Non-English speaking - Hearing Impaired

Additional Information

Official title Women's Health Initiative Memory Study--Epidemiology of Cognitive Health Outcomes
Principal investigator Stephen R. Rapp, PhD
Description Dementia is an illness characterized by a progressive decline in cognitive function. People with this disease experience memory, behavior, learning, and communication problems. The prevalence of dementia and other age-associated cognitive disorders is rising dramatically in the United States and around the world as the elderly population grows, and many of these affected individuals require assisted living and other costly forms of medical and personal care. As women go through menopause, many choose to take HT to relieve common menopausal symptoms, including hot flashes and mood swings. Unfortunately, the use of HT may place women at higher risk of experiencing a decline in cognitive function and at an increased risk of dementia, even after stopping HT. In the WHIMS study, women received HT, either as estrogen alone or as estrogen and progesterone combined, or placebo. This study will examine WHIMS participants to assess the prevalence of dementia and cognitive decline as these women grow older. Study researchers will attempt to determine whether HT increases the risk of dementia. This study will enroll women who are participating in the WHIMS study. Participants will be contacted by telephone annually; there will be no in-person study visits. Study staff will conduct interviews and administer questionnaires to participants to assess cognitive function, memory, attention, executive function, verbal fluency, depression, sleep disturbance, and dementia characteristics.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Wake Forest University Health Sciences.