Investigating tau biomarkers in older adults with late-onset psychosis

Tau Biomarkers in Late-onset Psychosis (LOP)

This study is trying to see if older adults with late-onset psychosis are at a higher risk for developing Alzheimer's disease by looking at new blood tests and brain scans.

Quick facts

• Study type: Observational
• Enrollment: 16 (estimated)
• Ages: 65 Years to 85 Years
• Sex: All
• Sponsor: Northwell Health (Academic / other)
• Locations: 1 site (Manhasset, New York)
• Trial ID: NCT06336382 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the relationship between late-onset psychosis and the risk of developing neurodegenerative diseases, particularly Alzheimer's disease. It will utilize novel blood biomarkers, PET imaging tracers, and non-invasive testing to assess elderly individuals experiencing psychotic symptoms without prior dementia. The study will compare these individuals to healthy elderly controls to better understand the biological mechanisms linking psychosis and dementia. By confirming the hypothesis that psychotic symptoms may indicate impending neurodegeneration, the research seeks to provide insights into early intervention strategies.

Who should consider this trial

Good fit: Ideal candidates are elderly individuals aged 65-85 with late-onset non-affective primary psychotic disorders and normal cognitive function.

Not a fit: Patients with affective or psychotic disorders such as bipolar disorder or schizoaffective disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier identification and intervention for elderly patients at risk of developing dementia.

How similar studies have performed: While there is ongoing research into the links between psychosis and neurodegeneration, this specific approach utilizing tau biomarkers and PET imaging is relatively novel.

Eligibility criteria

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.

Where this trial is running

Manhasset, New York

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

Study contacts

• Principal investigator: Jeremy Koppel, MD — Northwell Health
• Study coordinator: Nichole Hoehn, MS

Conditions Late Onset Schizophrenia; Delusional Disorder