NCT05847192Recruiting
Tau Networks in Psychotic Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 91 (estimated)
- First submitted
- 17 Apr 2023
- Start date
- 13 Apr 2023
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Northwell Health
- Diseases
- Alzheimer disease
- NCT number
- NCT05847192
What you commit to
- Study type: Observational
- Planned participants: 91
- From 13 Apr 2023 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of metal implants such as pacemakers, ear implants, internal bullet fragments or shrapnel.
Other illness
- 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.
- 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:
Other
- Rosen-modified Hachinski Ischemia Score \> 4 at the screening visit.
- Inability to lie flat for 1 hour approximately.
- 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).
- \- Same criteria as AD participants above.
Who the study is looking for
- 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
- 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
Age in the registry: 65 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Feinstein Institutes for Medical Research Coordinator of this site? Confirm its status | Manhasset | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.