Environmental and Reproductive Health Risk for Lewy Body Dementia

Dementia With Lewy Bodies Clinical Trial

— LBD-TOROS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06005935
• Other study ID #: 805745
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: University of California, San Diego
• Contact: Hamidreza Ghodsi, MD
• Phone: 858-213-3069
• Email: hghodsi[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia With Lewy Bodies
• Lewy Body Dementia
• Lewy Body Disease
• Parkinson Disease
• Parkinson Disease Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	University of California San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	The Lewy Body Dementia Association (LBDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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