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Tau Networks in Psychotic Alzheimer's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years to 85 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To measure structural and functional brain networks properties in AD+P compared to AD-P patients and CUH participants using MRI; 3."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how tau, a protein linked to Alzheimer’s disease, may relate to seeing or hearing things that are not there or having false beliefs. It is for adults ages 65–85 with Alzheimer’s disease, including those with these symptoms, and healthy adults without memory or thinking problems.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • All participants must be ages 65–85.
  • Alzheimer’s group: Have a diagnosis of likely Alzheimer’s dementia under the study’s guidelines.
  • Alzheimer’s group: Score 10–26 on the MMSE, a memory and thinking test, and at least 0.5 on the Clinical Dementia Rating.
  • Alzheimer’s group: On a delayed story recall test, score 8 or less with 16+ years of schooling, 4 or less with 8–15 years, or 2 or less with 0–7 years.
  • Alzheimer’s group with psychotic symptoms: Meet all Alzheimer’s group rules and see or hear things that are not there, or have fixed false beliefs.
  • Healthy group: Have no known genetic risk factors for dementia and no complaints about memory or thinking.
  • Healthy group: Score at least 26 on the MMSE memory and thinking test.
  • Healthy group: On a delayed story recall test, score at least 9 with 16+ years of schooling, 5 with 8–15 years, or 3 with 0–7 years.

Who can't join

  • Both groups: Score above 4 on the Rosen-modified Hachinski test, which checks for signs of blood-flow problems linked to dementia, or have a history of stroke.
  • Have another important brain or nerve disorder besides likely Alzheimer’s, epilepsy, a movement disorder, or a past head injury that caused more than 15 minutes of unconsciousness.
  • Have type 2 diabetes treated with insulin, a history of heart or blood vessel disease, or an immune disease affecting the brain or spinal cord.
  • Have an important or unstable mental health disorder, including schizophrenia or another psychotic disorder, bipolar disorder, current major depression, or delirium (sudden confusion).
  • Have had alcohol or drug dependence or abuse in the past 5 years.
  • Have metal implants, such as a pacemaker or ear implant, or bullet fragments or shrapnel inside the body.
  • Cannot lie flat for about 1 hour.
  • Cannot hear the required sounds at 500, 1,000, and 6,000 Hz in both ears on the study’s hearing test. Hearing aids are allowed if hearing meets the minimum requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

NY