Cognitive Measures Comparison for Alzheimer's Disease Prevention

(NoMAD Trial)

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

400 Participants Needed

Trial Summary

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 data supports the effectiveness of this treatment for Alzheimer's disease prevention?

The research suggests that the No Practice Effects (NPE) cognitive battery and Miami Computerized Functional Assessment Scale (CFAS) have strong measurement properties and may be more effective in assessing cognitive changes without practice effects, compared to traditional measures like ADAS-Cog and PACC. This could potentially make them useful in tracking Alzheimer's disease progression and evaluating treatment effectiveness. ^{1 2 3 4 5}

How does this treatment for Alzheimer's disease prevention differ from others?

This treatment is unique because it uses two novel cognitive measures, the No Practice Effects (NPE) cognitive battery and the Miami Computerized Functional Assessment Scale (CFAS), which are designed to have strong psychometric properties and reduce practice effects, making them potentially more effective in assessing cognitive changes compared to traditional methods. ^{1 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Terry E. Goldberg, Ph.D.

Principal Investigator

Columbia University Medical Center/ New York State Psychiatric Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Development of novel measures for Alzheimer's disease prevention trials (NoMAD). [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Cognition and motor function: The gait and cognition pooled index. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Assessing cognition in Alzheimer disease research. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Measuring treatment response in Alzheimer's disease clinical trials. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Mayo-PACC: A parsimonious preclinical Alzheimer's disease cognitive composite comprised of public-domain measures to facilitate clinical translation. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Assessment of cognition in mild cognitive impairment: a comparative study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Measuring cognition and function in the preclinical stage of Alzheimer's disease. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

'Alzheimer's Progression Score': Development of a Biomarker Summary Outcome for AD Prevention Trials. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Testing for Use in Clinical Trials: A Comparison of the NIH Toolbox and Cogstate C3 Batteries. [2023]