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The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June 2023.
The U.S. Department of HHS Office of Human Research Protections (OHRP) issued a pause on human subjects research.
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| Name | Class |
|---|---|
| Columbia University | OTHER |
| University of Southern California | OTHER |
| Feinstein Institute for Medical Research | OTHER |
| University of Miami |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel measures of cognition and everyday function | Experimental | 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. |
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| Established measures of cognition and everyday function | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Practice Effects (NPE) cognitive battery, and Miami Computerized Functional Assessment Scale (CFAS) | Other | Novel measures of Cognitive and Everyday function |
|
| Measure | Description | Time Frame |
|---|---|---|
| Computerized Functional Assessment Scale (CFAS). | 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. | Baseline to Week 52; change in score will be assessed |
| No Practice Effect (NPE) Cognitive Battery. | 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. | Baseline to Week 52; change in score will be assessed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terry E. Goldberg, Ph.D. | Columbia University Medical Center/ New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| University of Miami |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27239497 | Background | Goldberg TE, Harvey PD, Wesnes KA, Snyder PJ, Schneider LS. Practice effects due to serial cognitive assessment: Implications for preclinical Alzheimer's disease randomized controlled trials. Alzheimers Dement (Amst). 2015 Mar 29;1(1):103-11. doi: 10.1016/j.dadm.2014.11.003. eCollection 2015 Mar. | |
| 33933666 | Derived |
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| OTHER |
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| Preclinical Alzheimer's Cognitive Composite (PACC), Alzheimer's Disease Assessment Scale-Cognitive Scale (ADAS-Cog), and Functional Assessment Questionnaire (FAQ) | Other | Established measures of Cognitive and Everyday Function |
|
| Miami |
| Florida |
| 33136 |
| United States |
| The Feinstein Institute for Medical Research | Manhasset | New York | 11030 | United States |
| New York State Psychiatric Institute | New York | New York | 11032 | United States |
| Bell SA, Cohen HR, Lee S, Kim H, Ciarleglio A, Andrews H, Rivera AM, Igwe K, Brickman AM, Devanand DP, Harvey PD, Schneider LS, Goldberg TE. Development of novel measures for Alzheimer's disease prevention trials (NoMAD). Contemp Clin Trials. 2021 Jul;106:106425. doi: 10.1016/j.cct.2021.106425. Epub 2021 Apr 30. |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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