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Cognitive Measures Comparison for Alzheimer's Disease Prevention (NoMAD Trial)

N/A

Waitlist Available

Led By Terry E. Goldberg, Ph.D.

Research Sponsored by New York State Psychiatric Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English speaking participants, ages 60-85 years

Be older than 18 years old

Must not have

Active treatment of cancer

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 52; change in score will be assessed

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare new measures of cognition and everyday function to established ones, in order to see which are more effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves cognitive testing rather than medication, there are no direct side effects from drugs. However, participants may experience fatigue or stress related to frequent testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 60 and 85 years old and speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving treatment for cancer.

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I am not taking antidepressants known for strong anticholinergic effects.

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

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I am a pre-menopausal woman and I am pregnant.

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I have had a stroke or am at high risk for heart disease.

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I have a neurological condition like MS, epilepsy, or significant brain injury.

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I have diabetes that has not been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 52; change in score will be assessed

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 52; change in score will be assessed

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 52; change in score will be assessed for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Computerized Functional Assessment Scale (CFAS).

No Practice Effect (NPE) Cognitive Battery.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Novel measures of cognition and everyday functionExperimental Treatment1 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 functionActive Control1 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.

0 / 8Eligibility criteria met