Alzheimer DiseaseNCT05847192
Tau Networks in Psychotic Alzheimer's Disease
An observational study of Alzheimer Disease and Alzheimer Disease With Delusions, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Alzheimer Disease With Delusions, Alzheimer Disease With Psychosis
- What is being tested?
- [18F]-PI2620 PET scan
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2023to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Alzheimer´s disease (AD) participants Alzheimer´s disease (AD) with psychotic symptoms Cognitively Unimpaired Healthy (CUH) participants
Who may be able to join
- 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
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Feinstein Institutes for Medical Research
Manhasset, New York, 11030
Erica Christen, MS, 516-562-3492, EChriste@northwell.edu
Michelle Gong, AS, 516-562-3492, MGong@northwell.edu
About this study
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.
Read the detailed description
The specific aims of this application are:
- To measure the regional distribution of tau aggregation in AD patients with psychosis (AD+P) compared to AD without psychosis (AD-P) and Cognitively Unimpaired Healthy (CUH) participants with the PET radiotracer [18F]-PI2620;
- To measure structural and functional brain networks properties in AD+P compared to AD-P patients and CUH participants using MRI;
- To examine the association of tau pathology with structural/functional network properties; electrophysiologic biomarkers of neurotransmission and neuroplasticity; and psychotic symptoms. The current project will determine whether identification of tau pathology, and associated network connectivity disruptions and sensorimotor gating impairments, may be informing as potential biomarkers for psychosis in AD. As severe adverse events are associated with atypical antipsychotics in AD psychosis, this work will provide insights into whether anti-tau therapies such as monoclonal antibodies to tau, now being investigated in clinical trials, may be effective in the antipsychotic treatment of AD.
- Being tested
- [18F]-PI2620 PET scan
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-PI2620 PET scanDiagnostic 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: [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. Receives: Diagnostic Test: [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. Receives: Diagnostic Test: [18F]-PI2620 PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tau PET scan
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.
Measured: 5 years
Secondary outcomes (1)
MRI of the brain
To measure brain networks in AD patients with and without psychosis compared to Cognitively Unimpaired Healthy subjects.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start13 Apr 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Koppel, Northwell Health
- Investigators
- Jeremy Koppel, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847192
- Sponsor's protocol ID
- 22-0394_AFA
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tau Networks in Psychotic Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05847192
- Acronym / sponsor ID
- 22-0394_AFA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The specific aims of this application are:
- To measure the regional distribution of tau aggregation in AD patients with psychosis (AD+P) compared to AD without psychosis (AD-P) and Cognitively Unimpaired Healthy (CUH) participants with the PET radiotracer [18F]-PI2620;
- To measure structural and functional brain networks properties in AD+P compared to AD-P patients and CUH participants using MRI;
- To examine the association of tau pathology with structural/functional network properties; electrophysiologic biomarkers of neurotransmission and neuroplasticity; and psychotic symptoms. The current project will determine whether identification of tau pathology, and associated network connectivity disruptions and sensorimotor gating impairments, may be informing as potential biomarkers for psychosis in AD. As severe adverse events are associated with atypical antipsychotics in AD psychosis, this work will provide insights into whether anti-tau therapies such as monoclonal antibodies to tau, now being investigated in clinical trials, may be effective in the antipsychotic treatment of AD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's disease | – | Diagnostic Test: [18F]-PI2620 PET scan* 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 | – | Diagnostic Test: [18F]-PI2620 PET scan- 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 | – | Diagnostic Test: [18F]-PI2620 PET scanAge 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Alzheimer´s disease (AD) participants Alzheimer´s disease (AD) with psychotic symptoms Cognitively Unimpaired Healthy (CUH) participants
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]-PI2620 PET scanThe 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. | Diagnostic test | Alzheimer's disease, Alzheimer's disease with psychosis, Cognitively Unimpaired Healthy |
Primary outcome
Tau PET scan
Time frame: 5 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.
1 secondary outcome
MRI of the brain
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeremy Koppel, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Alzheimer Disease With Delusions, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erica Christen, MS (516-562-3492, EChriste@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tau PET scan (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.