Development of Novel Measures for Alzheimer's Disease Prevention Trials

Healthy Participants Clinical Trial

— NoMAD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03900273
• Other study ID #: 7672
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2023
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Healthy Participants

Intervention

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

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California
United States	The Feinstein Institute for Medical Research	Manhasset	New York
United States	University of Miami	Miami	Florida
United States	New York State Psychiatric Institute	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Columbia University, Feinstein Institute for Medical Research, University of Miami, University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to Week 52; change in score will be assessed
Primary	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.	Baseline to Week 52; change in score will be assessed