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Observational Study of Tau Networks in Alzheimer's Disease with Psychosis

This research study is looking at the brain mechanisms that lead to psychotic symptoms in people with Alzheimer's disease (AD). Researchers will use a special type of scan called an [18F]-PI2620 PET scan to measure tau aggregation (a protein buildup linked to AD) in the brain. They will compare people with AD who have psychosis, people with AD who do not have psychosis, and healthy individuals. The study aims to understand how tau pathology (the presence of abnormal tau protein) might be connected to psychosis in AD. You may be able to join if you are 65-85 years old and have a diagnosis of probable Alzheimer's disease. The study will measure tau PET scans over 5 years. The current status of this study is unclear.

Study design
This is an observational study with a planned enrollment of 91 participants. It compares different groups of people to understand brain mechanisms.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your tau PET scan will be measured at 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05847192

Tau Networks in Psychotic Alzheimer's Disease

Recruiting
Not specifiedAges 65–85Observational
Northwell Health
~91 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:[18F]-PI2620 PET scan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tau PET scan
Measured over 5 years

Conditions

Alzheimer Disease
Alzheimer Disease With Delusions
Alzheimer Disease With Psychosis

Explore related trials

Alzheimer's DiseaseAlzheimer's disease with psychosis

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Jeremy Koppel, MD · PRINCIPAL_INVESTIGATOR · Northwell Health

Who to contact

Erica Christen, MS
[email protected]
516-562-3492
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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).
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

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.

What this trial measures

  • Tau PET scan5 years

    To measure the distribution of tau aggregation in AD patients with and without psychosis, compared to cognitively unimpaired healthy subjects with the PET radiotracer \[18F\]-PI2620.