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Tau Networks in Psychotic Alzheimer's Disease

Northwell Health · NCT05847192

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 65–85 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
91
US sites recruiting
1
Study start
April 13, 2023
Record last updated
April 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

This research project aims to understand the brain mechanisms behind the manifestation of psychotic symptoms in Alzheimer´s disease (AD), and nature of the unique relationship with tau pathology. Amongst the cognitive manifestations of psychosis are impairments related to frontal circuits (social cognition, working memory and executive function deficits). The investigator's previous work suggests a role of tau pathology (one of the hallmarks of AD neuropathology) in the manifestation of psychosis in AD. However, the cerebral mechanisms that underly this association remain poorly understood. The overarching aim of the study is is to investigate the mechanisms by which tau network pathology may promote the presentation of psychosis in AD.

Being studied: [18F]-PI2620 PET scan

Conditions: Alzheimer Disease; Alzheimer Disease With Delusions; Alzheimer Disease With Psychosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria Alzheimer´s disease (AD) participants:

  • Age 65-85 years old.
  • Diagnosis of probable AD dementia according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.
  • Mini-Mental State Examination (MMSE) score ≥ 10 and ≤ 26 at the screening visit.
  • Clinical Dementia Rating (CDR) score ≥ 0.5.
  • Logical Memory delay score of ≤8 for 16+ years of education, ≤4 for 8-15 years of education, and ≤2 for 0-7 years of education

Exclusion Criteria Alzheimer´s disease (AD) participants:

  • Rosen-modified Hachinski Ischemia Score > 4 at the screening visit.
  • History of stroke.
  • Evidence of a clinically relevant neurological disorder other than probable AD at the screening visit. Participants with 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, autoimmune disease affecting the CNS, or delirium.
  • Evidence of a clinically relevant or unstable psychiatric disorder, based on DSM-5 criteria, including schizophrenia or other psychotic disorder, bipolar disorder, delirium, or current/active major depression.
  • History of alcoholism or drug dependency/abuse within the last 5 years before screening.
  • Presence of metal implants such as pacemakers, ear implants, internal bullet fragments or shrapnel.
  • Inability to lie flat for 1 hour approximately.
  • hearing impairment as evidenced by the inability to hear 500, 1000 and 6000 Hz bilaterally on an OAE evaluation. Subjects with hearing aides will be allowed to participate if they meet minimum hearing requirements.

Specific Inclusion Criteria for Alzheimer´s disease (AD) with Psychotic symptoms:

  • All the criteria for AD are met.
  • Presence of one (or more) of the following symptoms:
  • Visual or auditory hallucinations (e.g., seeing silent individuals standing in the room, seeing children in the yard, or seeing animals in the house).
  • Delusions (fixed false beliefs that the patient believes to be true, e.g., that the spouse is unfaithful, that possessions are being stolen, or that one is not who one claims to be).

Inclusion Criteria Cognitively Unimpaired Healthy (CUH) participants:

  • Age 65-85 years old.
  • No known genetic risk factors for dementia.
  • No cognitive complaint
  • Mini-Mental State Examination (MMSE) score ≥ 26 at the screening visit.
  • Logical Memory delay score of ≥9 for 16+ years of education, ≥5 for 8-15 years of education, and ≥3 for 0-7 years of education

Exclusion Criteria Cognitively Unimpaired Healthy (CUH) participants:

  • Same criteria as AD participants above.

Recruiting US locations

  • The Feinstein Institutes for Medical Research

    Manhasset, NY 11030

    Site contact: Erica Christen, MS · 516-562-3492 · EChriste@northwell.edu

Study contacts (from the official record)

  • Erica Christen, MS · 516-562-3492 · EChriste@northwell.edu
  • Michelle Gong, AS · 516-562-3492 · MGong@northwell.edu
Tau Networks in Psychotic Alzheimer's Disease (NCT05847192) | Bored Studies