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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    380
  • sponsor
    New York State Psychiatric Institute
Updated on 25 July 2022
Accepts healthy volunteers

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.

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 380 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.

Details
Condition Healthy Participants
Treatment 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)
Clinical Study IdentifierNCT03900273
SponsorNew York State Psychiatric Institute
Last Modified on25 July 2022

Eligibility

Yes No Not Sure

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
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