Lewy Body DiseaseNCT07849413
Visual Hallucinations in Lewy Body Diseases
An observational study of Lewy Body Disease and Lewy Body Dementia, run by NYU Langone Health at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Lewy Body Disease, Lewy Body Dementia, Parkinson Disease
- What is being tested?
- Behavioral Tasks and MRI/MEG Scans
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to 31 Aug 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- LBD Patients with or without visual hallucinations
- 18 - 90 yrs
- Fluent in English or Spanish
- Score at least 24 out of 30 on the MoCA
- Diagnosed with Lewy Body diseases, including Parkinson's disease and Lewy Body dementias (Parkinson's disease dementia and dementia with Lewy bodies)
- Age-matched controls (healthy volunteers)
Show all 9Show fewer
- 18 - 90 yrs
- Fluent in English or Spanish
- Score at least 26 out of 30 on the MoCA
Who cannot join
- LBD Patients with or without visual hallucinations
- History of traumatic brain injury or significant head trauma
- History of significant neurologic disorders other than Lewy body diseases
- Meets DSM-IV criteria for substance abuse or dependence
- For MRI studies, any contraindication to MRI as determined by the MRI Safety Screening Form
- Age-matched controls (healthy volunteers)
Show all 10Show fewer
- History of traumatic brain injury or significant head trauma
- History of significant neurologic disorders other than Lewy body diseases
- Meets DSM-IV criteria for substance abuse or dependence
- For MRI studies, any contraindication to MRI as determined by the MRI Safety Screening Form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Understanding Neural Mechanisms Underlying Visual Hallucinations in Lewy Body Diseases
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:
- LBD patients who experience visual hallucinations
- LBD patients who do not have visual hallucinations
- 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.
- Conditions
- Lewy Body Disease, Lewy Body Dementia, Parkinson Disease, Parkinson Disease Dementia, Visual Hallucinations
- Being tested
- Behavioral Tasks, MRI/MEG Scans
- Medical subject headings
- Lewy Body Disease, Parkinson Disease, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral TasksBehavioural
Delivered as part of outpatient experimental sessions.
MRI/MEG ScansOther
Delivered as part of outpatient experimental sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Behavioral Tasks; Other: MRI/MEG Scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in recognition rate
Behavioral responses assessed by changes in recognition rate from pre- to post-disambiguation stage.
Measured: Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)
Euclidean distance in neural activity patterns
Neural response patterns assessed by Euclidean distance in neural activity pattern between pre- and post-disambiguation stages.
Measured: Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start15 Sep 2026
- Primary completion31 Aug 2031 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lewy Body DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Biyu He, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849413
- Sponsor's protocol ID
- 15-01323
- Other IDs
- 1R01NS148898
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Neural Mechanisms Underlying Visual Hallucinations in Lewy Body Diseases
- ClinicalTrials.gov ID
- NCT07849413
- Acronym / sponsor ID
- 15-01323
- Conditions
- Lewy Body Disease, Lewy Body Dementia, Parkinson Disease, Parkinson Disease Dementia, Visual Hallucinations
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 31 Aug 2031 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- LBD patients who experience visual hallucinations
- LBD patients who do not have visual hallucinations
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Lewy Body Diseases who experience visual hallucinations | – | Behavioral: Behavioral Tasks, Other: MRI/MEG ScansPatients 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 | – | Behavioral: Behavioral Tasks, Other: MRI/MEG ScansPatients 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 | – | Behavioral: Behavioral Tasks, Other: MRI/MEG ScansPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- LBD Patients with or without visual hallucinations
- 18 - 90 yrs
- Fluent in English or Spanish
- Score at least 24 out of 30 on the MoCA
- Diagnosed with Lewy Body diseases, including Parkinson's disease and Lewy Body dementias (Parkinson's disease dementia and dementia with Lewy bodies)
Key exclusion criteria (10 listed)
- LBD Patients with or without visual hallucinations
- History of traumatic brain injury or significant head trauma
- History of significant neurologic disorders other than Lewy body diseases
- Meets DSM-IV criteria for substance abuse or dependence
- For MRI studies, any contraindication to MRI as determined by the MRI Safety Screening Form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral TasksDelivered as part of outpatient experimental sessions. | Behavioural | Age-matched controls, Patients with Lewy Body Diseases who do not experience visual hallucinations, Patients with Lewy Body Diseases who experience visual hallucinations |
| MRI/MEG ScansDelivered as part of outpatient experimental sessions. | Other | Age-matched controls, Patients with Lewy Body Diseases who do not experience visual hallucinations, Patients with Lewy Body Diseases who experience visual hallucinations |
Primary outcome
Changes in recognition rate
Time frame: Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)
Behavioral responses assessed by changes in recognition rate from pre- to post-disambiguation stage.
Euclidean distance in neural activity patterns
Time frame: Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)
Neural response patterns assessed by Euclidean distance in neural activity pattern between pre- and post-disambiguation stages.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Biyu He, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lewy Body Disease and Lewy Body Dementia, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan-hao Wu (212.263.0307, Yuanhao.Wu@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in recognition rate (time frame: Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.