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NCT06336382Recruiting

Tau Biomarkers in Late-onset Psychosis (LOP)

Source: ClinicalTrials.gov · Last updated 29 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
16 (estimated)
First submitted
20 Mar 2024
Start date
16 Feb 2024
Primary completion date
31 Dec 2026
Lead sponsor
Jeremy Koppel
NCT number
NCT06336382

What you commit to

  • Study type: Observational
  • Planned participants: 16
  • From 16 Feb 2024 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Presence of metal implants such as pacemakers, ear implants, internal bullet fragments or shrapnel.

Other illness

  • 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
  • History of alcoholism or drug dependency/abuse within the last 5 years before screening.
  • 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.

Other

  • Modified Hachinski ischemia score of more than 4.
  • Inability to lie flat for 1 hour approximately.

Who the study is looking for

  • 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).

Age in the registry: 65 years to 85 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Feinstein Institutes for Medical Research
Coordinator of this site? Confirm its status
ManhassetUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.