Cognitive Measures Comparison for Alzheimer's Disease Prevention
(NoMAD Trial)
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.12345Why 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.678910Who 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo baseline assessments using either novel or established cognitive and functional measures
Serial Assessments
Participants receive three serial assessments over a one year period at baseline, week 12, and week 52
Follow-up
Participants are monitored for changes in cognitive and functional measures after the final assessment
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)
Find a Clinic Near You
Who Is Running the Clinical Trial?
New York State Psychiatric Institute
Lead Sponsor
Columbia University
Collaborator
Feinstein Institute for Medical Research
Collaborator
University of Miami
Collaborator
University of Southern California
Collaborator