RECRUITING

Tau Biomarkers in Late-onset Psychosis (LOP)

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Conditions

Late Onset SchizophreniaDelusional Disorder (Late Onset)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Tau Biomarkers in Late-onset Psychosis (LOP)

Quick Facts

Study Start:2024-02-16
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06336382

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female, aged 65-85 years.
  2. 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. 3. Caregiver available to provide collateral history and participation in informant-based ratings (NPI,CDR)
  4. 4. Clinical Dementia Rating (CDR) score of 0 or 0.5.
  5. 5. Mini-Mental State Examination (MMSE) score ≥ 24 and at the screening visit.
  6. 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. 7. Ability to hear 500, 1000 and 1500 Hz bilaterally on a hearing evaluation (hearing aids permitted).
  1. 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. 2. Evidence of a clinically relevant neurological disorder
  3. 3. Modified Hachinski ischemia score of more than 4.
  4. 4. History of alcoholism or drug dependency/abuse within the last 5 years before screening.
  5. 5. Presence of metal implants such as pacemakers, ear implants, internal bullet fragments or shrapnel.
  6. 6. Inability to lie flat for 1 hour approximately.
  7. 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.

Contacts and Locations

Study Contact

Nichole Hoehn, MS
CONTACT
516-562-3492
nhoehn@northwell.edu
Erica Christen, MS
CONTACT
516-562-3492
EChriste@northwell.edu

Principal Investigator

Jeremy Koppel, MD
PRINCIPAL_INVESTIGATOR
Northwell Health

Study Locations (Sites)

The Feinstein Institutes for Medical Research
Manhasset, New York, 11030
United States

Collaborators and Investigators

Sponsor: Jeremy Koppel

  • Jeremy Koppel, MD, PRINCIPAL_INVESTIGATOR, Northwell Health

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

Study Start Date2024-02-16
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-02-16
Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Late Onset Schizophrenia
  • Delusional Disorder (Late Onset)