Understanding brain mechanisms of psychosis in Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research project investigates the brain mechanisms that contribute to psychotic symptoms in Alzheimer's disease (AD), focusing on the relationship with tau pathology. The study aims to measure tau aggregation in AD patients with and without psychosis using PET scans, and to analyze structural and functional brain networks through MRI. Additionally, it will explore how tau pathology correlates with network properties and psychotic symptoms, potentially identifying biomarkers for psychosis in AD. Insights gained may inform the effectiveness of anti-tau therapies as alternatives to traditional antipsychotics.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Feinstein Institutes for Medical Research
  Manhasset, New York, United States Recruiting

Study contacts

• Principal investigator: Jeremy Koppel, MD — Northwell Health
• Study coordinator: Erica Christen, MS
• Email: EChriste@northwell.edu
• Phone: 516-562-3492

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.