Tau Networks in Psychotic Alzheimer's Disease

Part of paid clinical trials in Manhasset, New York.

Sponsor
Northwell Health
Study ID
NCT05847192
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • [18F]-PI2620 PET scan — DIAGNOSTIC_TEST
    The PET scan will measure the regional distribution of tau aggregation in AD patients with and without psychosis compared to Cognitively Unimpaired Healthy participants with the PET radiotracer \[18F\]-PI2620.

Study Details

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.

Key Dates

Start date
Apr 13, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
91 participants (estimated)

Arms

  • Arm: Alzheimer's disease
    * Age 65-85 years old. * Diagnosis of probable AD dementia according to 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 Participants will undergo neuropsychological examination, blood collection, sensorimotor gating/ERP testing, MRI and \[18F\]-PI2620 PET scan.
  • Arm: Alzheimer's disease with psychosis
    \- 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). Participants will undergo neuropsychological examination, blood collection, sensorimotor gating/ERP testing, MRI and \[18F\]-PI2620 PET scan.
  • Arm: Cognitively Unimpaired Healthy
    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 Participants will undergo neuropsychological examination, blood collection, sensorimotor gating/ERP testing, MRI and \[18F\]-PI2620 PET scan.

Primary Outcome Measure

Tau PET scan [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Feinstein Institutes for Medical ResearchManhassetNew York11030
Erica Christen, MS
[email protected]
516-562-3492
Michelle Gong, AS
[email protected]
516-562-3492

Find similar trials in Manhasset, NY

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
The Feinstein Institutes for Medical Research· Manhasset, NY

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