Development of Novel Measures of Cognition and Function for Alzheimer's Disease Prevention Trials
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Computerized Functional Assessment Scale (CFAS).
研究概览
简要总结
This protocol focuses on novel measures of cognition and everyday function that have robust psychometrics and reduced practiced effects. They will be deployed in a parallel group study in which participants are randomized to assessment type (novel vs established) and receive serial assessments over a one year period in order to highlight contrasts between novel and established measures.
详细描述
This protocol has the goal of validating novel cognitive and everyday functional measures that have sharply attenuated practice effects and are not prone to ceiling effects for use in preclinical Alzheimer's disease (AD) trials in which participants are cognitively within normal limits. To implement this, we will conduct an innovative parallel group study in which 400 healthy, non-cognitively impaired older subjects are randomized to one of two groups based on assessment type (novel instruments vs. established) and receive three serial assessments over a one year period. Novel cognitive measures include tests of executive function, episodic memory, and processing speed combined into a single composite. Novel functional measures involve computerized performance based, ecologically relevant instrumental activities. We will compare our novel No Practice Effects (NPE) cognitive battery and Miami Computerized Functional Assessment Scale (CFAS) against established measures that include the ADAS-COG in order to determine which battery (novel or established) has better psychometric properties and is less sensitive to practice effects in this clinical trials structure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking participants, ages 60-85 years
- •MMSE score of 24 or greater
- •Logical Memory II score of 9 or greater for subjects with 16 or more years of education, 5 or more for subjects with 8-15 years of education, and 3 or greater for subjects with 0-7 years of education
- •Presence of subjective memory complaints not exclusionary
- •A family member or other individual who is in contact with the subject and consents to serve as informant during the study.
排除标准
- •Diagnosis of stroke or excessive risk of CVD
- •Neurologic disease including movement disorders, MS, epilepsy, and TBI (with greater than 15 min loss of consciousness)
- •Untreated diabetes
- •Current DSM-5 Axis I psychiatric diagnosis of schizophrenia schizoaffective disorder or bipolar disorder; current major depression as determined by a Geriatric Depression Scale score of greater than
- •Current alcohol or substance use disorder
- •Active treatment of cancer
- •MMSE score below 24 and Logical Memory below 9 for subjects with 16 or more years of education, 5 for subjects with 8-15 years of education, and 3 for subjects with 0-7 years of education
- •Females who are pre-menopausal and are pregnant.
- •Use of antidepressants with large anticholinergic properties will be excluded. These include: amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, isocarboxazide, lithium, maprotiline, mirtazapine, nortriptyline, tranylcypromine trimipramine, and phenelzine.
研究组 & 干预措施
Novel measures of cognition and everyday function
No Practice Effects (NPE) cognitive battery
Miami Computerized Functional Assessment Scale (CFAS)
Participants will receive three serial assessments of the NPE and CFAS over a one year period. Assessments will take place at baseline, week 12, and week 52.
干预措施: No Practice Effects (NPE) cognitive battery, and Miami Computerized Functional Assessment Scale (CFAS) (Other)
Established measures of cognition and everyday function
Preclinical Alzheimer's Cognitive Composite (PACC)
Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
Functional Assessment Questionnaire (FAQ).
Participants will receive three serial assessments of the PACC, ADAS-Cog and FAQ over a one year period.
Assessments will take place at baseline, week 12, and week 52.
干预措施: Preclinical Alzheimer's Cognitive Composite (PACC), Alzheimer's Disease Assessment Scale-Cognitive Scale (ADAS-Cog), and Functional Assessment Questionnaire (FAQ) (Other)
结局指标
主要结局
Computerized Functional Assessment Scale (CFAS).
时间窗: Baseline to Week 52; change in score will be assessed
Novel computerized measure of everyday function. Testing format is a set of simulations (ATM use, Kiosk ticket purchase , Prescription refill , and Doctor's visit ). We will construct a z score based on the "rate" measure which accounts for both speed and accuracy. Higher scores suggest greater cognitive function while lower scores indicate greater cognitive impairment.
No Practice Effect (NPE) Cognitive Battery.
时间窗: Baseline to Week 52; change in score will be assessed
Novel measure of cognitive function. Scores can be age-adjusted by decade. The majority of the subtests ( including tests of Cognitive Control/Executive Processes, Working Memory,Speed of Processing,Verbal Fluency and Episodic Memory)are computerized or partially computerized. All tests have three equivalent alternate forms. We will construct a z-score averaged composite based on scores of the subtests at baseline. Higher scores suggest greater cognitive function while lower scores indicate greater cognitive impairment.
次要结局
未报告次要终点
研究者
Terry Goldberg
Professor of Medical Psychology
New York State Psychiatric Institute