Recruiting

Observational Study

Sponsor:

Northwell Health

Code:

NCT05847192

Conditions

Alzheimer Disease

Alzheimer Disease With Delusions

Alzheimer Disease With Psychosis

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Interventions

[18F]-PI2620 PET scan

Study Details

Brief summary:

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.

Conditions

Alzheimer Disease

Alzheimer Disease With Delusions

Alzheimer Disease With Psychosis

Study ID

NCT05847192

Start date

Apr 13, 2023

Status verified date

Apr, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

91 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

[18F]-PI2620 PET scan

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.

Primary outcome measure

  • Tau PET scan [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Erica Christen, MS

516-562-3492EChriste@northwell.edu

Michelle Gong, AS

516-562-3492MGong@northwell.edu

Locations

The Feinstein Institutes for Medical Research

Recruiting

Manhasset, New York, United States, 11030

Contacts

Erica Christen, MS

516-562-3492EChriste@northwell.edu

Michelle Gong, AS

516-562-3492MGong@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-04-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.