Effects of Hormone Replacement Therapy on Cognitive Aging: Women's Health Initiative Study of Cognitive Aging (WHISCA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,303
- 试验地点
- 1
- 主要终点
- Determine if 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.
研究概览
简要总结
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.
详细描述
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?
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Enrolled in WHIMS
- •At least 65 years old
- •Not diagnosed with dementia
排除标准
- •Women younger than 65 years of age
- •Have dementia
- •not enrolled in WHIMS
结局指标
主要结局
Determine if 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.
时间窗: Annual assessment done annually.
The primary outcome measures are the changes in scores from a standardized neuropsychological assessment will be conducted annually. The battery is comprised primarily of tests of memory, and includes the following tests in specified order: the Prospective Memory Tests, Primary Mental Abilities Vocabulary Test, the California Verbal Learning Test, the Benton Visual Retention Test, Card Rotations Test, the Finger Tapping Test, the Letter and Semantic Fluency Test and the Digit Span Test. In addition, the Positive and Negative Affect Scale and Geriatric Depression Scale will be administered.
次要结局
- 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.(measured over life of the study)