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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 52; change in score will be assessed
Awards & highlights
NoMAD Trial 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.Check my eligibility
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.See study design
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.
NoMAD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 60 and 85 years old and speak English.
NoMAD Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Computerized Functional Assessment Scale (CFAS).
No Practice Effect (NPE) Cognitive Battery.
NoMAD 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.
Find a Location
Who is running the clinical trial?
Columbia UniversityOTHER
1,431 Previous Clinical Trials
2,460,431 Total Patients Enrolled
Feinstein Institute for Medical ResearchOTHER
21 Previous Clinical Trials
5,272 Total Patients Enrolled
University of MiamiOTHER
898 Previous Clinical Trials
409,251 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have a certain score on a memory test based on the number of years you went to school.I am currently receiving treatment for cancer.I am between 60 and 85 years old and speak English.If you have memory problems, you can still participate in the study.You scored 24 or higher on the MMSE test.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.I am a pre-menopausal woman and I am pregnant.I have had a stroke or am at high risk for heart disease.I have a neurological condition like MS, epilepsy, or significant brain injury.Your memory and thinking skills test scores are below a certain level, depending on how many years of education you have.I have diabetes that has not been treated.
Research Study Groups:
This trial has the following groups:- Group 1: Novel measures of cognition and everyday function
- Group 2: Established measures of cognition and everyday function
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Healthy Subjects Patient Testimony for trial: Trial Name: NCT03900273 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrolling in this research endeavor a possibility for me?
"This clinical study seeks 400 elderly individuals aged between 60 and 85 years old who display subjective memory complaints. To be accepted, participants must possess a Logical Memory II score of 9 or more if they have 16+ years of education; 5 or more with 8-15 years; 3 (at least) for those educated 0-7; an MMSE score of 24+; and the availability of an informant to serve as contact during the trail. Additionally, all candidates must be proficient in English."
Answered by AI
Are any openings still available for participation in this clinical experiment?
"According to clinicaltrials.gov, this trial is currently recruiting volunteers and has been active since it was initially posted on February 25th 2019 with the last update occuring on August 8th 2022."
Answered by AI
Is the enrollment age for this experiment inclusive of individuals above 20 years old?
"This trial has a specific age requirement, with participants needing to be between 60 and 85 years old. For those under 18 or over 65, 73 and 900 trials respectively are available for consideration."
Answered by AI
How widespread is the implementation of this research project?
"At present, 4 locations are making the trial available to potential participants: The New york State Psychiatric Institute in NYC, The Feinstein Institute for Medical Research in Manhasset, University of Miami in Florida and one other site."
Answered by AI
How many participants are included in this research initiative?
"In order to make this medical trial a success, 400 eligible participants are needed. Interested individuals can register in New york State Psychiatric Institute (New York) or The Feinstein Institute for Medical Research (Manhasset)."
Answered by AI
Who else is applying?
What state do they live in?
New York
California
Florida
How old are they?
18 - 65
What site did they apply to?
Other
New York State Psychiatric Institute
University of Miami
University of Southern California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
Approximately how many visits to the trial site would this require?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
A family history of mental impairment at advanced ages. I’m getting older and am concerned about maintain my mental capacity.
PatientReceived no prior treatments
I'm interested in accelerating research efforts on cognitive function.
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- University of Southern California: < 48 hours
Average response time
- < 2 Days
Typically responds via
Phone Call
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