Development of Novel Measures for Alzheimer's Disease Prevention Trials

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Conditions studied: Healthy Participants

In brief

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.

Key facts

Study ID

NCT03900273

Run by

New York State Psychiatric Institute

People needed

400

Starts

2019-02-25

Expected to finish

2026-08-31

Last updated by the study team

2025-10-31

Who can join

Age: 60 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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.

Where it is running

• University of Southern California — Los Angeles, California, United States
• University of Miami — Miami, Florida, United States
• The Feinstein Institute for Medical Research — Manhasset, New York, United States
• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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