Tau Biomarkers in Late-onset Psychosis (LOP)
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 Start (Actual) 16 February 2024
🗓️ Primary Completion (Estimated) 31 December 2026
✅ Study Completion (Estimated) 30 June 2027
👥 Enrollment (Estimated) 16
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Manhasset, New York, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 65 Years to 85 Years (OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 March 2024
  • First Submitted that Met QC Criteria 27 March 2024
  • First Posted 28 March 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 March 2024
  • Last Update Posted 28 March 2024
  • Last Verified March 2024