Tau Biomarkers in Late-onset Psychosis (LOP)

Recruiting now

Conditions studied: Late Onset Schizophrenia, Delusional Disorder (Late Onset)

In brief

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.

Key facts

Study ID

NCT06336382

Run by

Jeremy Koppel

People needed

16

Starts

2024-02-16

Expected to finish

2027-06-30

Last updated by the study team

2025-09-29

Who can join

Age: 65 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, aged 65-85 years.
• Diagnosis of late-onset non-affective primary psychotic disorder consistent with either very late-onset schizophrenia-like psychosis (VLOSP, International Late-Onset Schizophrenia Group consensus criteria, Howard et al., 2000) or delusional disorder (DSM-5 criteria)
• Caregiver available to provide collateral history and participation in informant-based ratings (NPI,CDR)
• Clinical Dementia Rating (CDR) score of 0 or 0.5.
• Mini-Mental State Examination (MMSE) score ≥ 24 and at the screening visit.
• Normal memory function (to rule-out mild cognitive impairment, MCI) documented by scoring within 1.5 SD range in education adjusted norms of the Logical Memory II subscale
• Ability to hear 500, 1000 and 1500 Hz bilaterally on a hearing evaluation (hearing aids permitted).

You may not qualify if…

• Participants with affective and psychotic disorders including bipolar disorder, schizoaffective disorder, active major depression; insulin dependent type 2 diabetes; a history of CVD; a history of epilepsy; a history of TBI with greater than 15 minutes of loss of consciousness; a movement disorder including Parkinson's disease; stroke; autoimmune disease affecting the CNS; substance abuse disorder; or active delirium/encephalopathy.
• Evidence of a clinically relevant neurological disorder
• Modified Hachinski ischemia score of more than 4.
• History of alcoholism or drug dependency/abuse within the last 5 years before screening.
• Presence of metal implants such as pacemakers, ear implants, internal bullet fragments or shrapnel.
• Inability to lie flat for 1 hour approximately.
• Hearing impairment as evidenced by the inability to hear 500, 1000 and 1500 Hz bilaterally on a hearing evaluation. Subjects with hearing aids will be allowed to participate if they meet minimum hearing requirements.

Where it is running

• The Feinstein Institutes for Medical Research — Manhasset, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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