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

May 30, 2023 updated by: Terry Goldberg, New York State Psychiatric Institute

Development of Novel Measures of Cognition and Function for Alzheimer's Disease Prevention Trials

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • New York
      • Manhasset, New York, United States, 11030
        • The Feinstein Institute for Medical Research
      • New York, New York, United States, 11032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 52; change in score will be assessed
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.
Baseline to Week 52; change in score will be assessed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

University of Miami
Columbia University
University of Southern California
Feinstein Institute for Medical Research

Investigators

  • Principal Investigator: Terry E. Goldberg, Ph.D., Columbia University Medical Center/ New York State Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2019

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 3, 2019

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7672

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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