Recruiting

Observational Study

Sponsor:

Jeremy Koppel

Code:

NCT06336382

Conditions

Late Onset Schizophrenia

Delusional Disorder (Late Onset)

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

Tau PET imaging scan

Study Details

Brief summary:

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

Late Onset Schizophrenia

Delusional Disorder (Late Onset)

Study ID

NCT06336382

Start date

Feb 16, 2024

Status verified date

Sep, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female, aged 65-85 years.
2. 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)
3. Caregiver available to provide collateral history and participation in informant-based ratings (NPI,CDR)
4. Clinical Dementia Rating (CDR) score of 0 or 0.5.
5. Mini-Mental State Examination (MMSE) score ≥ 24 and at the screening visit.
6. 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
7. Ability to hear 500, 1000 and 1500 Hz bilaterally on a hearing evaluation (hearing aids permitted).

Exclusion Criteria:

1. 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.
2. Evidence of a clinically relevant neurological disorder
3. Modified Hachinski ischemia score of more than 4.
4. History of alcoholism or drug dependency/abuse within the last 5 years before screening.
5. Presence of metal implants such as pacemakers, ear implants, internal bullet fragments or shrapnel.
6. Inability to lie flat for 1 hour approximately.
7. 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.

Study Design

Enrollment

16 participants

Anticipated

Interventions and Outcome Measures

Interventions

Tau PET imaging scan

Subjects will be scanned with novel tau PET tracer \[18F\] PI-2620 to determine whether neurofibrillary tangle pathology is present.

Primary outcome measure

  • Quantification of neurofibrillary tangle pathology in subjects via PET [18F]PI-2620 radiotracer uptake. [ Time Frame: Each subject will have one PET imaging scan at visit 3 (week 4). ]

Central Contacts and Locations

Central contacts

Locations

The Feinstein Institutes for Medical Research

Recruiting

Manhasset, New York, United States, 11030

Contacts

More Information

Sponsor

Jeremy Koppel

Last update posted

Sep 29, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jeremy Koppel on 2025-09-29.