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RecruitingNCT07849413Updated Sep 30, 2026

Visual Hallucinations in Lewy Body Diseases

An observational study in Lewy Body Disease, Lewy Body Dementia and Parkinson Disease, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by NYU Langone Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
234
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed description

Visual hallucinations are highly prevalent in Lewy Body Diseases (LBD), a prominent group of neurodegenerative disorders that includes Dementia with Lewy Bodies, Parkinson's disease, and Parkinson's disease dementia. Currently, scientists do not fully understand how the brain creates these false visual images. This lack of knowledge makes it difficult to develop effective treatments.

This study aims to understand the neural mechanisms that give rise to these hallucinatory experiences. The study will include three groups of volunteers:

  1. LBD patients who experience visual hallucinations
  2. LBD patients who do not have visual hallucinations
  3. age-matched volunteers without a significant neurological history

During the study, participants will undergo safe, non-invasive brain imaging scans. While being scanned, they will either rest or complete visual computer tasks.

The results of this study will help map the brain networks responsible for visual hallucinations. These insights will help researchers develop better, targeted interventions for this disabling symptom.

02

Conditions studied

  • Lewy Body Disease
  • Lewy Body Dementia
  • Parkinson Disease
  • Parkinson Disease Dementia
  • Visual Hallucinations
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Three subject cohorts will be recruited for this study: 1) LBD patients who experience visual hallucinations (LBD-VH group); 2) patients diagnosed with LBD without any visual hallucinations (LBD-non-VH group, control arm); 3) age and demographically matched controls.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
234 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Behavioral: Behavioral Tasks · Other: MRI/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.

    Behavioral: Behavioral Tasks · Other: MRI/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.

    Behavioral: Behavioral Tasks · Other: MRI/MEG Scans

Interventions

  • BehavioralBehavioral Tasks

    Delivered as part of outpatient experimental sessions.

  • OtherMRI/MEG Scans

    Delivered as part of outpatient experimental sessions.

05

What researchers measure

Primary outcomes

  1. Changes in recognition rate

    Behavioral responses assessed by changes in recognition rate from pre- to post-disambiguation stage.

    Time frame: Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)

  2. Euclidean distance in neural activity patterns

    Neural response patterns assessed by Euclidean distance in neural activity pattern between pre- and post-disambiguation stages.

    Time frame: Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)

06

Study locations

1 of 1 sites recruiting
  • NYU Langone Health
    New York, New York 10016, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — The de-identified participant data from the final research dataset will be shared upon reasonable request by the time of publication or, the end of the period of performance, including any no-cost extension. Data will remain available for at least as long as required by the applicable repository and/or journal policies. De-identified behavioral and fMRI data underlying peer-reviewed publications will be shared through established repositories, such as OpenNeuro, GitHub, and figshare. Data will be shared by the time of publication or, for other findings, by the end of the award's period of performance, and will remain available for at least as long as required by the applicable repository and/or journal policies. Repository links will be provided when available. All potentially identifying information will be fully removed prior to releasing the data.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07849413
Lead sponsor
NYU Langone Health
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Responsible party
Sponsor
First posted
Sep 30, 2026
Start date
Sep 15, 2026
Primary completion
Aug 31, 2031 (estimated)
Completion
Aug 31, 2031 (estimated)
Last update
Sep 30, 2026

Study contacts

Yuan-hao Wu
Contact
Yuanhao.Wu@nyulangone.org
212.263.0307
Nalini Jeet
Contact
Nalini.Jeet@nyulangone.org
212-263-0228
Biyu He, PhD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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