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Development of Novel Measures for Alzheimer's Disease Prevention Trials (NoMAD)

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ClinicalTrials.gov Identifier: NCT03900273
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : March 4, 2020
Sponsor:
Collaborators:
Columbia University
University of Southern California
Feinstein Institute for Medical Research
University of Miami
Information provided by (Responsible Party):
Terry Goldberg, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Healthy Participants Other: No Practice Effects (NPE) cognitive battery, and Miami Computerized Functional Assessment Scale (CFAS) Other: Preclinical Alzheimer's Cognitive Composite (PACC), Alzheimer's Disease Assessment Scale-Cognitive Scale (ADAS-Cog), and Functional Assessment Questionnaire (FAQ) Not Applicable

Detailed Description:
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 320 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development of Novel Measures of Cognition and Function for Alzheimer's Disease Prevention Trials
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Other: No Practice Effects (NPE) cognitive battery, and Miami Computerized Functional Assessment Scale (CFAS)
Novel measures of Cognitive and Everyday function

Active Comparator: 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.

Other: Preclinical Alzheimer's Cognitive Composite (PACC), Alzheimer's Disease Assessment Scale-Cognitive Scale (ADAS-Cog), and Functional Assessment Questionnaire (FAQ)
Established measures of Cognitive and Everyday Function




Primary Outcome Measures :
  1. Computerized Functional Assessment Scale (CFAS). [ Time Frame: 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.

  2. No Practice Effect (NPE) Cognitive Battery. [ Time Frame: 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.



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. English speaking participants, ages 60-85 years
  2. MMSE score of 24 or greater
  3. 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
  4. Presence of subjective memory complaints not exclusionary
  5. A family member or other individual who is in contact with the subject and consents to serve as informant during the study.

Exclusion Criteria:

  1. Diagnosis of stroke or excessive risk of CVD
  2. Neurologic disease including movement disorders, MS, epilepsy, and TBI (with greater than 15 min loss of consciousness)
  3. Untreated diabetes
  4. 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
  5. Active treatment of cancer
  6. 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
  7. Females who are pre-menopausal and are pregnant.
  8. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900273


Contacts
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Contact: Terry E. Goldberg, Ph.D. 646-774-5215 teg2117@cumc.columbia.edu
Contact: Davangere P. Devanand, M.D. 646-774-8658 dpd3@cumc.columbia.edu

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Nadine Diaz, MSW    323-442-7600    nadine.diaz@med.usc.edu   
Principal Investigator: Lon Schneider, M.D.         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Philip D. Harvey, Ph.D.    305-243-4094    pharvey@med.miami.edu   
Principal Investigator: Philip D. Harvey, Ph.D.         
United States, New York
The Feinstein Institute for Medical Research Recruiting
Manhasset, New York, United States, 11030
Contact: James B. Steele    516-562-0417    jsteele5@northwell.com   
Principal Investigator: Marc Gordon, M.D.         
New York State Psychiatric Institute Recruiting
New York, New York, United States, 11032
Contact: Sophie Bell, BS    646-774-8691    Sophie.Bell@nyspi.columbia.edu   
Principal Investigator: Terry E. Goldberg, Ph.D.         
Sponsors and Collaborators
New York State Psychiatric Institute
Columbia University
University of Southern California
Feinstein Institute for Medical Research
University of Miami
Investigators
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Principal Investigator: Terry E. Goldberg, Ph.D. Columbia University Medical Center/ New York State Psychiatric Institute

Publications:
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Responsible Party: Terry Goldberg, Professor of Medical Psychology, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03900273    
Other Study ID Numbers: Novel Measures
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Terry Goldberg, New York State Psychiatric Institute:
Alzheimer's disease
Neuropsychological Testing
Healthy Older Individuals
Psychometrics
Prevention
Clinical Trial
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders