Actively Recruiting

Age: 65Years - 85Years
All Genders
NCT06336382

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

Age: 65Years - 85Years
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

The Feinstein Institutes for Medical Research

Manhasset, New York, United States, 11030

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here