Environmental and Reproductive Health Risk for Lewy Body Dementia

NCT06005935 | Active Not Recruiting

• 1 other identifier: 805745
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this survey study is to identify environmental, occupational and reproductive health risk factors for Lewy body dementia, which includes Parkinson's disease dementia and dementia with Lewy bodies. Participants will complete a one-time survey online or over the phone that includes questions on environmental, occupational factors they may have been exposed to and on medical history including reproductive health. Researchers will then compare the responses of people with Lewy body dementia and people without Parkinson's or memory/thinking problems to see which factors play a role in Lewy body dementia. Identifying risk factors can guide future treatment efforts and provide more insight to this dementia.

Conditions

Lewy Body Dementia; Parkinson Disease Dementia; Dementia With Lewy Bodies

Outcome Measures

Primary Outcomes (1)

• Environmental, occupational, reproductive health factors

  Responses of participants with Lewy body dementia and controls completing the survey including questions on environmental, occupational and reproductive health factors will be compared to determine which factors play a role in Lewy body dementia.

  1 year

Study Arms (2)

Participants with Lewy body dementia

50 women and 50 men with a clinical diagnosis of Lewy body dementia (Parkinson's disease dementia or dementia with Lewy bodies) will be included. If assistance is needed to complete the survey, care partners can help, however, they cannot answer the questions on the participant's behalf without the participant's contribution.

Other: Survey

Controls

50 women and 50 men with normal cognition and without Parkinson's disease will be included. Normal cognition will be determined using a screening questionnaire in the beginning of the survey to determine eligibility.

Other: Survey

Interventions

Survey OTHER

Participants will complete a one-time survey including questions on demographics, health status, reproductive health history, environmental and occupational factors one may or may not have been exposed to. The survey can be completed online or over the phone, and should last approximately 30-45 minutes.

Controls; Participants with Lewy body dementia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with Lewy body dementia will include 50 women and 50 men with a clinical diagnosis of Lewy body dementia (Parkinson's disease dementia or dementia with Lewy bodies). If assistance is needed to complete the survey, care partners can help, however, they cannot answer the questions on the participant's behalf without the participant's contribution. Controls will include 50 women and 50 men with similar age as the participants with Lewy body dementia. Normal cognition will be determined using a screening questionnaire in the beginning of the survey to determine eligibility.

You may qualify if:

• For participants with Lewy body dementia: Clinical diagnosis of Lewy body dementia (Parkinson's disease dementia or dementia with Lewy bodies)
• For controls: Normal cognition
• Implication of consent to participate by stating consent verbally over the phone or by selecting the appropriate response on the online survey to indicate consent

You may not qualify if:

• For controls: Parkinson's disease or dementia diagnosis

Sponsors & Collaborators

• University of California, San Diego: lead
• The Lewy Body Dementia Association (LBDA): collaborator

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

Location

Related Links

• Information on the study

MeSH Terms

Conditions

Lewy Body Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ece Bayram, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 23, 2023
• Study Start: August 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)