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

Primary Purpose

Healthy Participants

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No Practice Effects (NPE) cognitive battery, and Miami Computerized Functional Assessment Scale (CFAS)
Preclinical Alzheimer's Cognitive Composite (PACC), Alzheimer's Disease Assessment Scale-Cognitive Scale (ADAS-Cog), and Functional Assessment Questionnaire (FAQ)
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy Participants focused on measuring Alzheimer's disease, Neuropsychological Testing, Healthy Older Individuals, Psychometrics, Prevention, Clinical Trial

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Southern California
  • University of Miami
  • The Feinstein Institute for Medical Research
  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Novel measures of cognition and everyday function

Established measures of cognition and everyday function

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2019
Last Updated
May 30, 2023
Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University, University of Southern California, Feinstein Institute for Medical Research, University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT03900273
Brief Title
Development of Novel Measures for Alzheimer's Disease Prevention Trials
Acronym
NoMAD
Official Title
Development of Novel Measures of Cognition and Function for Alzheimer's Disease Prevention Trials
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University, University of Southern California, Feinstein Institute for Medical Research, University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Participants
Keywords
Alzheimer's disease, Neuropsychological Testing, Healthy Older Individuals, Psychometrics, Prevention, Clinical Trial

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Novel measures of cognition and everyday function
Arm Type
Experimental
Arm Description
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.
Arm Title
Established measures of cognition and everyday function
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
No Practice Effects (NPE) cognitive battery, and Miami Computerized Functional Assessment Scale (CFAS)
Intervention Description
Novel measures of Cognitive and Everyday function
Intervention Type
Other
Intervention Name(s)
Preclinical Alzheimer's Cognitive Composite (PACC), Alzheimer's Disease Assessment Scale-Cognitive Scale (ADAS-Cog), and Functional Assessment Questionnaire (FAQ)
Intervention Description
Established measures of Cognitive and Everyday Function
Primary Outcome Measure Information:
Title
Computerized Functional Assessment Scale (CFAS).
Description
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.
Time Frame
Baseline to Week 52; change in score will be assessed
Title
No Practice Effect (NPE) Cognitive Battery.
Description
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.
Time Frame
Baseline to Week 52; change in score will be assessed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry E. Goldberg, Ph.D.
Organizational Affiliation
Columbia University Medical Center/ New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
The Feinstein Institute for Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
11032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27239497
Citation
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.
Results Reference
background
PubMed Identifier
33933666
Citation
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.
Results Reference
derived

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Development of Novel Measures for Alzheimer's Disease Prevention Trials

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