Environmental and Reproductive Health Risk for Lewy Body Dementia (LBD-TOROS)

Sex-Specific Environmental and Reproductive Health Risk Factors for Lewy Body Dementia

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.

Study Overview

• Status: Recruiting
• Conditions: Dementia With Lewy Bodies; Lewy Body Dementia; Parkinson Disease Dementia
• Intervention / Treatment: Other: Survey

Detailed Description

Lewy body dementia, including Parkinson's disease dementia and dementia with Lewy bodies, is one of the most common dementias and does not have a cure for now. It can occur differently for women and men, although we are not sure why. The ratio of women to men for the disease prevalence changes with older age, suggesting a potential role for reproductive factors, particularly for women. Environmental factors impact the risk for other types of dementia, although such factors have not been clearly described in Lewy body dementia specifically. Women and men may get exposed to different environmental and occupational risk factors, and the impact of factors can differ for women and men. By using one-time survey that can be completed online or over the phone, we will try to understand which environmental, occupational or reproductive health factors play a role in Lewy body dementia for women and men. By comparing the survey responses of people with Lewy body dementia and people without Parkinson's or memory/thinking problems, we aim to identify specific risk factors for women and men that can guide future treatment efforts and provide more insight into this dementia.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Hamidreza Ghodsi, MD; Phone Number: 858-213-3069; Email: hghodsi@health.ucsd.edu
• Study Contact Backup: Name: Ece Bayram, MD, PhD; Phone Number: 858-246-2546; Email: ebayram@health.ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California San Diego
      • Contact: Hamidreza Ghodsi, MD; Phone Number: 858-213-3069; Email: hghodsi@health.ucsd.edu
      • Contact: Ece Bayram, MD, PhD; Phone Number: 8582462546; Email: ebayram@health.ucsd.edu
      • Principal Investigator: Ece Bayram, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• For controls: Parkinson's disease or dementia diagnosis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: The Lewy Body Dementia Association (LBDA)
• Investigators: Principal Investigator: Ece Bayram, MD, PhD, University of California, San Diego

Publications and helpful links

Helpful Links

• Link to find out more and participate in the online survey

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 20, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Tauopathies; Parkinson Disease; Dementia; Alzheimer Disease; Lewy Body Disease
• Other Study ID Numbers: 805745

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No