NCT03900273Suspended
Development of Novel Measures for Alzheimer's Disease Prevention Trials
Development of Novel Measures of Cognition and Function for Alzheimer's Disease Prevention Trials
Source: ClinicalTrials.gov · Last updated 31 Oct 2025
Reason given: The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June 2023. The U.S. Department of HHS Office of Human Research Protections (OHRP) issued a pause on human subjects research.
Brief summary (registry, in English)
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.
- Status (registry)
- Suspended
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 15 Mar 2019
- Start date
- 25 Feb 2019
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- New York State Psychiatric Institute
- Diseases
- Alzheimer disease
- NCT number
- NCT03900273
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of stroke or excessive risk of CVD
- Neurologic disease including movement disorders, MS, epilepsy, and TBI (with greater than 15 min loss of consciousness)
- Untreated diabetes
- Current DSM-5 Axis I psychiatric diagnosis of schizophrenia schizoaffective disorder or bipolar disorder; 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
Other
- MMSE score below 24 and Logical Memory below 9 for subjects with 16 or more years of education, 5 for subjects with 8-15 years of education, and 3 for subjects with 0-7 years of education
- Females who are pre-menopausal and are pregnant.
- 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.
Who the study is looking for
- English speaking participants, ages 60-85 years
- MMSE score of 24 or greater
- Logical Memory II score of 9 or greater for subjects with 16 or more years of education, 5 or more for subjects with 8-15 years of education, and 3 or greater for subjects with 0-7 years of education
- Presence of subjective memory complaints not exclusionary
- A family member or other individual who is in contact with the subject and consents to serve as informant during the study.
Age in the registry: 60 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Southern California | Los Angeles | United States | Unknown status |
| The Feinstein Institute for Medical Research | Manhasset | United States | Unknown status |
| University of Miami | Miami | United States | Unknown status |
| New York State Psychiatric Institute | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.