Understanding brain mechanisms of psychosis in Alzheimer's disease
Tau Networks in Psychotic Alzheimer's Disease
This study is trying to understand how changes in the brain related to tau protein might cause psychotic symptoms in people with Alzheimer's disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 91 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (Manhasset, New York) |
| Trial ID | NCT05847192 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65-85 with a diagnosis of probable Alzheimer's disease and specific cognitive assessment scores.
Not a fit: Patients with significant comorbid neurological disorders or those with a history of stroke may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for psychosis in Alzheimer's disease patients.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated a link between tau pathology and psychotic symptoms in Alzheimer's disease.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Manhasset, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.