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Development of Novel Measures for Alzheimer's Disease Prevention Trials
NoMAD
1 other identifier
interventional
400
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2019
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2019
CompletedFirst Submitted
Initial submission to the registry
March 15, 2019
CompletedFirst Posted
Study publicly available on registry
April 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
ExpectedOctober 31, 2025
October 1, 2025
6.5 years
March 15, 2019
October 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Novel measures of cognition and everyday function
EXPERIMENTALNo 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.
Established measures of cognition and everyday function
ACTIVE COMPARATORPreclinical 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.
Interventions
Novel measures of Cognitive and Everyday function
Established measures of Cognitive and Everyday Function
Eligibility Criteria
You may qualify if:
- 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
- A family member or other individual who is in contact with the subject and consents to serve as informant during the study.
You may not qualify if:
- 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 5. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- New York State Psychiatric Institutelead
- Columbia Universitycollaborator
- University of Southern Californiacollaborator
- Feinstein Institute for Medical Researchcollaborator
- University of Miamicollaborator
Study Sites (4)
University of Southern California
Los Angeles, California, 90033, United States
University of Miami
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
Related Publications (2)
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.
PMID: 27239497BACKGROUNDBell 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.
PMID: 33933666DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Terry E. Goldberg, Ph.D.
Columbia University Medical Center/ New York State Psychiatric Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medical Psychology
Study Record Dates
First Submitted
March 15, 2019
First Posted
April 3, 2019
Study Start
February 25, 2019
Primary Completion
August 31, 2025
Study Completion (Estimated)
August 31, 2026
Last Updated
October 31, 2025
Record last verified: 2025-10