Actively Recruiting
Tau Biomarkers in Late-onset Psychosis (LOP)
Led by Jeremy Koppel · Updated on 2025-09-29
16
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
Sponsors
J
Jeremy Koppel
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Hallucinations or delusions that occur for the first time in older people with no acute medical problems or mood symptoms may be related to impending dementia. This study aims to confirm this hypothesis using novel blood biomarkers and Positron Emission Tomography (PET) imaging tracers, as well as non-invasive testing.
CONDITIONS
Official Title
Tau Biomarkers in Late-onset Psychosis (LOP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 65 to 85 years
- Diagnosed with late-onset non-affective primary psychotic disorder such as very late-onset schizophrenia-like psychosis or delusional disorder
- Caregiver available to provide collateral history and participate in informant-based ratings
- Clinical Dementia Rating score of 0 or 0.5
- Mini-Mental State Examination score of 24 or higher at screening
- Normal memory function based on Logical Memory II subscale within 1.5 standard deviations of education-adjusted norms
- Ability to hear 500, 1000 and 1500 Hz bilaterally on hearing test (hearing aids permitted)
You will not qualify if you...
- Diagnosis of affective or psychotic disorders including bipolar disorder, schizoaffective disorder, or active major depression
- Insulin dependent type 2 diabetes
- History of cardiovascular disease, epilepsy, traumatic brain injury with over 15 minutes loss of consciousness, Parkinson's disease, stroke, CNS autoimmune disease, substance abuse disorder, or active delirium/encephalopathy
- Evidence of clinically relevant neurological disorder
- Modified Hachinski ischemia score above 4
- Alcoholism or drug dependency/abuse within the last 5 years
- Presence of metal implants such as pacemakers, ear implants, internal bullet fragments, or shrapnel
- Inability to lie flat for about 1 hour
- Hearing impairment that prevents hearing 500, 1000 and 1500 Hz bilaterally on hearing evaluation (hearing aids allowed if minimum hearing is met)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Feinstein Institutes for Medical Research
Manhasset, New York, United States, 11030
Actively Recruiting
Research Team
N
Nichole Hoehn, MS
CONTACT
E
Erica Christen, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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