Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT07849413

Conditions

Lewy Body Disease

Lewy Body Dementia

Parkinson Disease

Parkinson Disease Dementia

Visual Hallucinations

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Behavioral Tasks

MRI/MEG Scans

Study Details

Brief summary:

The goal of this basic experimental study involving humans (BESH) protocol is to improve the understanding of neural mechanisms underlying visual hallucinations in Lewy Body diseases to inform future treatment developments.

Conditions

Lewy Body Disease

Lewy Body Dementia

Parkinson Disease

Parkinson Disease Dementia

Visual Hallucinations

Study ID

NCT07849413

Start date

Sep 15, 2026

Status verified date

Sep, 2026

Completion date

Aug 31, 2031

Anticipated

Primary completion date

Aug 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

I) LBD Patients with or without visual hallucinations

1. 18 - 90 yrs
2. Fluent in English or Spanish
3. Score at least 24 out of 30 on the MoCA
4. Diagnosed with Lewy Body diseases, including Parkinson's disease and Lewy Body dementias (Parkinson's disease dementia and dementia with Lewy bodies)

II) Age-matched controls (healthy volunteers)

1. 18 - 90 yrs
2. Fluent in English or Spanish
3. Score at least 26 out of 30 on the MoCA

Exclusion Criteria:

I) LBD Patients with or without visual hallucinations

1. History of traumatic brain injury or significant head trauma
2. History of significant neurologic disorders other than Lewy body diseases
3. Meets DSM-IV criteria for substance abuse or dependence
4. For MRI studies, any contraindication to MRI as determined by the MRI Safety Screening Form

II) Age-matched controls (healthy volunteers)

1. History of traumatic brain injury or significant head trauma
2. History of significant neurologic disorders other than Lewy body diseases
3. Meets DSM-IV criteria for substance abuse or dependence
4. For MRI studies, any contraindication to MRI as determined by the MRI Safety Screening Form

Study Design

Enrollment

234 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Lewy Body Diseases who experience visual hallucinations

Patients will complete between one and multiple outpatient experimental sessions, depending on the specific scientific question being addressed, the type of data required by the investigator and the patient's availability.

Potential interventions include: behavioral tasks, MRI scans, MEG scans.

Patients with Lewy Body Diseases who do not experience visual hallucinations

Patients will complete between one and multiple outpatient experimental sessions, depending on the specific scientific question being addressed, the type of data required by the investigator and the patient's availability.

Potential interventions include: behavioral tasks, MRI scans, MEG scans.

Age-matched controls

Patients will complete between one and multiple outpatient experimental sessions, depending on the specific scientific question being addressed, the type of data required by the investigator and the patient's availability.

Potential interventions include: behavioral tasks, MRI scans, MEG scans.

Interventions

Behavioral Tasks

Delivered as part of outpatient experimental sessions.

MRI/MEG Scans

Delivered as part of outpatient experimental sessions.

Primary outcome measure

  • Changes in recognition rate [ Time Frame: Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day) ]
  • Euclidean distance in neural activity patterns [ Time Frame: Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day) ]

Central Contacts and Locations

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-01. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.