No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
65 – 85
Sex
Any
Study type
Observational
Participants needed
91 (estimated)
Sponsor
Northwell Health · Other
Who this trial is looking for
This trial is looking for older adults with Alzheimer’s disease who experience psychotic symptoms, such as hallucinations or delusions. Participants will help researchers understand how certain brain changes are related to these symptoms.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 65 and 85 years old.
I have been diagnosed with probable Alzheimer’s disease.
I have a Mini-Mental State Examination score between 10 and 26.
I have a Clinical Dementia Rating score of at least 0.5.
I have the required Logical Memory delay score based on my education level.
I have psychotic symptoms, like hallucinations or delusions.
You may not be able to join if
I have had a stroke.
I have a significant neurological disorder other than Alzheimer’s.
I have a serious psychiatric disorder, like schizophrenia or bipolar disorder.
I have a history of alcoholism or drug dependency in the last 5 years.
I have metal implants like a pacemaker.
I cannot lie flat for about one hour.
I have trouble hearing sounds at specific frequencies.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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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 Deme…
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.
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