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Novel Measures for Alzheimer's Disease Prevention Trials (NoMAD)

Recruiting

This study is recruiting healthy volunteers to help validate new measures of cognition and everyday function for Alzheimer's clinical trials in which participants are cognitively normal but show preclinical signs of the disease.

Minimum Age Maximum Age Gender Healthy Volunteers
60 Years 85 Years All Yes
February 25, 2019
March 31, 2023
320

  • English speaking
  • Mini-Mental State Examination score of 24 or greater
  • Logical Memory II score of 9 or greater for individuals with 16 or more years of education, 5 or more for individuals with 8 to 15 years of education, and 3 or greater for individuals with 0 to 7 years of education
  • Subjective memory complaints not exclusionary
  • Family member or other individual who has regular contact with the participant and can provide information during the study

  • Diagnosis of stroke or excessive risk of cardiovascular disease
  • Neurologic disease, including movement disorders, multiple sclerosis, epilepsy, and traumatic brain injury with loss of consciousness for 15 minutes or more
  • Untreated diabetes
  • Psychiatric diagnosis of schizophrenia or bipolar disorder, or current major depression as determined by a Geriatric Depression Scale score of greater than 5
  • Current alcohol or substance use disorder
  • Active treatment of cancer
  • Women who are premenopausal or are pregnant
  • Prohibited medications: antidepressants with large anticholinergic properties, including amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, isocarboxazide, lithium, maprotiline, mirtazapine, nortriptyline, tranylcypromine trimipramine, and phenelzine

Participants will be randomly assigned to one of two groups based on assessment type (novel instruments versus established) and receive three assessments over a 1-year period. Novel cognitive measures include tests of executive function, memory, and processing speed and involve computerized performance-based activities. These novel assessments, called the No Practice Effects cognitive battery and Miami Computerized Functional Assessment Scale, will be compared against established measures, such as the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-COG).

Name City State Zip Status Primary Contact
University of Southern California
Los Angeles California 90033 Recruiting Nadine Diaz
323-442-7600
nadine.diaz@med.usc.edu
University of Miami
Miami Florida 33136 Recruiting Philip D. Harvey, PhD
305-243-4094
pharvey@med.miami.edu
The Feinstein Institute for Medical Research
Manhasset New York 11030 Recruiting James B. Steele
516-562-0417
jsteele5@northwell.com
New York State Psychiatric Institute
New York New York 11032 Recruiting Antoinette K. Swanson
646-774-8635
kara.antoinette@nyspi.columbia.edu

New York State Psychiatric Institute

  • Columbia University
  • University of Southern California
  • Feinstein Institute for Medical Research
  • University of Miami

Name Role Affiliation
Terry E. Goldberg, PhD Principal Investigator Columbia University Medical Center/ New York State Psychiatric Institute

Name Phone Email
Terry E. Goldberg, PhD 646-774-5215 teg2117@cumc.columbia.edu
Davangere P. Devanand, MD 646-774-8658 dpd3@cumc.columbia.edu

NCT03900273

Development of Novel Measures of Cognition and Function for Alzheimer's Disease Prevention Trials