Clinical trial NCT03900273: Development of Novel Measures for Alzheimer's Disease Prevention Trials
Official title: Development of Novel Measures of Cognition and Function for Alzheimer's Disease Prevention Trials
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Healthy Participants
Keywords: Alzheimer's disease
Neuropsychological Testing
Healthy Older Individuals
Psychometrics
Prevention
Clinical Trial
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Columbia University
name: University of Southern California
name: Feinstein Institute for Medical Research
name: University of Miami
First posted: 2019-04-03
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Computerized Functional Assessment Scale (CFAS).
timeFrame: Baseline to Week 52; change in score will be assessed
measure: No Practice Effect (NPE) Cognitive Battery.
timeFrame: Baseline to Week 52; change in score will be assessed
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Manhasset
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia University Medical Center/ New York State Psychiatric Institute
name: Terry E. Goldberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.