Overview

This trial is active, not recruiting.

Condition healthy
Sponsor Wake Forest School of Medicine
Start date July 1999
End date September 2007
Trial size 2303 participants
Trial identifier NCT00631332, NO1-AG-9-2115

Summary

The Women's Health Initiative Study of Cognitive Aging (WHISCA) is a two-armed, randomized, placebo controlled, clinical trial designed to assess the efficacy of postmenopausal hormone therapy (HT) on age related changes in specific cognitive functions. WHISCA is an ancillary study to the Women's Health Initiative (WHI) and the WHI Memory Study (WHIMS) and has enrolled 2303 women aged 66 to 84 years who did not meet the criteria for dementia. WHISCA is investigating the effects of hormone therapy on rates of change over time in memory, other aspects of cognition (language, attention, spatial ability), motor function, and mood.

Objectives

- Does HT protect against age-associated memory and cognitive longitudinal decline in women age 65 and older?

- What is the rate of change in memory and other cognitive abilities in women receiving HT compared to women receiving placebo?

- Does the addition of progesterone to HT modify the effects of estrogen on memory and other cognitive abilities?

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Measure
Does HT protect against age-associated memory and cognitive longitudinal decline in women age 65 and older as measured over time by a series of cognitive tests administered annually?
time frame: Annual assessment done annually.

Secondary Outcomes

Measure
To determine the long-term effects of HT on changes in memory, other cognitive functions, and affect; and to investigate predictors of the transitions between normal aging and mild cognitive impairment and mild cognitive impairment and dementia.
time frame: measured over lift of the study

Eligibility Criteria

Female participants from 65 years up to 90 years old.

Inclusion Criteria: - Enrolled in WHIMS - At least 65 years old - Not diagnosed with dementia Exclusion Criteria: - Women younger than 65 years of age - Have dementia - not enrolled in WHIMS

Additional Information

Official title Effects of Hormone Replacement Therapy on Cognitive Aging: Women's Health Initiative Study of Cognitive Aging (WHISCA)
Trial information was received from ClinicalTrials.gov and was last updated in February 2008.
Information provided to ClinicalTrials.gov by Wake Forest School of Medicine.