NCT05847192 Tau Networks in Psychotic Alzheimer's Disease
| NCT ID | NCT05847192 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwell Health |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 91 participants |
| Start Date | 2023-04-13 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 91 participants in total. It began in 2023-04-13 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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.
Contact & Investigator
Jeremy Koppel, MD
PRINCIPAL INVESTIGATOR
Northwell Health
Frequently Asked Questions
Who can join the NCT05847192 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 85 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05847192 currently recruiting?
Yes, NCT05847192 is actively recruiting participants. Contact the research team at EChriste@northwell.edu for enrollment information.
Where is the NCT05847192 trial being conducted?
This trial is being conducted at Manhasset, United States.
Who is sponsoring the NCT05847192 clinical trial?
NCT05847192 is sponsored by Northwell Health. The principal investigator is Jeremy Koppel, MD at Northwell Health. The trial plans to enroll 91 participants.
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