Tau Networks in Psychotic Alzheimer's Disease
Northwell Health · NCT05847192
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
Similar studies in New York
All mental health studies in New York →- RecruitingHealthy volunteersPhase 1/Phase 2
Study of Cannabidiol and Neuroimaging on Stress
Icahn School of Medicine at Mount Sinai
- Location
- New York, NY
- Eligibility basics
- Ages 18–25
- RecruitingHealthy volunteersPhase 1
MDMA-Assisted Therapy for Mental Healthcare Providers
Rachel Yehuda
- Location
- New York, NY
- Eligibility basics
- Ages 18+
- RecruitingHealthy volunteersEarly Phase 1
Anxiety During Abstinence in AUD
Columbia University
- Location
- New York, NY
- Eligibility basics
- Ages 21–55
- RecruitingHealthy volunteers
DESCANSO, a Mental Health Intervention for Depression, Insomnia, and Fatigue Symptoms in Latino People With Cancer
Ponce Medical School Foundation, Inc.
- Location
- Commack, NY + 6 other US sites
- Eligibility basics
- Ages 21–100