Cognitive Measures Comparison for Alzheimer's Disease Prevention

(NoMAD Trial)

Not currently recruiting at 3 trial locations

Overseen By Davangere P. Devanand, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York State Psychiatric Institute

Must not be taking: Antidepressants

Disqualifiers: Stroke, CVD, Neurologic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to measure thinking skills and daily function in individuals at risk for Alzheimer’s disease. Researchers aim to compare these new tests with older ones in tracking changes over a year. Participants will be divided into two groups: one using the novel tests and the other using established ones, with assessments at three different times. The trial suits English-speaking individuals aged 60-85 who notice memory issues but do not have serious health conditions like stroke or untreated diabetes. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance early detection methods for Alzheimer's disease.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain antidepressants with strong anticholinergic effects, such as amitriptyline and imipramine. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What prior data suggests that this protocol is safe?

Research has shown that the No Practice Effects (NPE) cognitive tests are safe and easy to use. Designed to reduce learning effects, these tests can be taken multiple times without causing stress or confusion, providing a gentle way to monitor changes in thinking skills.

The Miami Computerized Functional Assessment Scale (CFAS) simulates everyday activities through a computer program. Although specific safety data is not mentioned, similar tools are generally safe as they only involve computer use.

Both the NPE and CFAS assess thinking and daily skills rather than medication use, which typically results in fewer risks for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares innovative cognitive assessment tools with established ones to find the most effective way to detect and monitor Alzheimer's disease in its early stages. Unlike traditional assessments like the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) and the Functional Assessment Questionnaire (FAQ), the trial includes novel tools like the No Practice Effects (NPE) cognitive battery and the Miami Computerized Functional Assessment Scale (CFAS). These new measures aim to provide more accurate and consistent results over time, potentially leading to earlier and more reliable detection of cognitive changes. By evaluating these methods over a full year, the trial could revolutionize how we track Alzheimer's progression and enhance prevention strategies.

What evidence suggests that this trial's measures could be effective for Alzheimer's prevention?

This trial will compare novel measures of cognition and everyday function with established measures for Alzheimer's disease prevention. Research has shown that the No Practice Effects (NPE) cognitive battery and the Miami Computerized Functional Assessment Scale (CFAS), used in one arm of this trial, are promising tools for evaluating Alzheimer's disease. These tools demonstrate strong measurement accuracy and reduced practice effects, potentially making them more reliable than traditional methods.

Participants in another arm of this trial will undergo assessments using the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog), Functional Assessment Questionnaire (FAQ), and Preclinical Alzheimer's Cognitive Composite (PACC). These well-established tools effectively track cognitive and functional decline in Alzheimer's patients over time.

Both the new and established tools in this trial enhance understanding of cognitive changes, each offering distinct advantages. The new tools might provide a fresh approach to monitoring disease progression, while the established methods offer a reliable baseline for comparison. ^{6 7 8 9 10}

Who Is on the Research Team?

Terry E. Goldberg, Ph.D.

Principal Investigator

Columbia University Medical Center/ New York State Psychiatric Institute

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals aged 60-85 with memory concerns but no severe cognitive impairment (MMSE score ≥24). They must have a reliable informant and meet certain education-specific memory criteria. Excluded are those with significant neurological diseases, untreated diabetes, active cancer treatment, or using specific antidepressants.

Inclusion Criteria

You need to have a certain score on a memory test based on the number of years you went to school.

If you have memory problems, you can still participate in the study.

You scored 24 or higher on the MMSE test.

Exclusion Criteria

I am currently receiving treatment for cancer.

I am not taking antidepressants known for strong anticholinergic effects.

I have been diagnosed with a major psychiatric disorder and/or have a current issue with alcohol or substance use.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments using either novel or established cognitive and functional measures

1 week

1 visit (in-person)

Serial Assessments

Participants receive three serial assessments over a one year period at baseline, week 12, and week 52

52 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in cognitive and functional measures after the final assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alzheimer's Disease Assessment Scale-Cognitive Scale (ADAS-Cog)
• Functional Assessment Questionnaire (FAQ)
• Miami Computerized Functional Assessment Scale (CFAS)
• No Practice Effects (NPE) cognitive battery
• Preclinical Alzheimer's Cognitive Composite (PACC)

Trial Overview

The study compares novel cognitive and functional measures designed to prevent Alzheimer's disease against established ones over one year. Participants will be randomly assigned to either the new tests or traditional ones to see which better detects changes in cognition and daily function.

How Is the Trial Designed?

Group I: Novel measures of cognition and everyday function Experimental Treatment 1 Intervention

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.

Group II: Established measures of cognition and everyday function Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Feinstein Institute for Medical Research

Collaborator

Trials

22

Recruited

5,700+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Published Research Related to This Trial

There is a growing need for quick and reliable cognitive assessments to identify early signs of cognitive decline, especially as research shifts towards developing treatments for Alzheimer's disease before symptoms appear.

This review systematically evaluates 16 cognitive measures, primarily computer-based, to determine their effectiveness in distinguishing between healthy individuals and those showing subtle cognitive changes, providing a framework for selecting appropriate tools for clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of cognition in mild cognitive impairment: a comparative study. Snyder, PJ., Jackson, CE., Petersen, RC., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10001317/

Development of novel measures for Alzheimer's disease ...

This study aims to evaluate if the NPE and CFAS demonstrate stronger psychometric properties and reduced practice effects compared with established measures.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714421001610

Development of novel measures for Alzheimer's disease ...

This study aims to evaluate if the NPE and CFAS demonstrate stronger psychometric properties and reduced practice effects compared with established measures.

3.

alz-journals.onlinelibrary.wiley.com

alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.13757

Novel measures of cognition and function for the AD spectrum ...

This study derived composite scores for two novel cognitive measures, the No Practice Effect (NPE) battery and the Miami Computerized ...

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researchgate.net

researchgate.net/publication/351243880_Development_of_novel_measures_for_Alzheimer's_disease_prevention_trials_NoMAD

Development of novel measures for Alzheimer's disease ...

Two novel measures of cognition (No Practice Effects (NPE) cognitive battery and Miami Computerized Functional Assessment Scale (CFAS)) were ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10020887/

Novel Approaches to Measuring Neurocognitive Functions ...

The Miami Computerized Functional Assessment Scale (CFAS) is another novel measure that is designed to measure functions related to instrumental activities of ...

6.

fasoutcomes.com

fasoutcomes.com/Content.aspx?ContentID=12

Child And Adolescent Functional Assessment Scale - CAFAS

The CAFAS is quickly completed by an assessor (10 minutes), based on information collected during a typical clinical assessment.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00985725

Study Details | NCT00985725 | SPD489 in Adults With ...

MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a ...

8.

researchgate.net

researchgate.net/profile/Philip-Harvey-3

Philip D Harvey PhD Professor at University of Miami

We developed a novel computer-based functional skills assessment and training (FUNSAT) program, which includes simulations of everyday technology-based tasks ( ...

9.

miamidade.gov

miamidade.gov/govaction/legistarfiles/Matters/Y2024/242146.pdf

MDC001

The supplemental planning activities include performing Road Safety Audits (RSAs) along five. High Injury Network (HIN) corridors and a research ...

10.

floridahealth.gov

floridahealth.gov/_media/miami-dade/community-reports/miamidade-cha.pdf

2022 COMMUNITY HEALTH ASSESSMENT

Appendix I: The Local Public Health System Assessment (LPHSA) Full Report. Appendix II: The Forces of Change Assessment Full Report.