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

Sponsor
University of California, San Diego (Other)
Overall Status
Recruiting
CT.gov ID
NCT06005935
Collaborator
The Lewy Body Dementia Association (LBDA) (Other)
200
1
12
16.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Sex-Specific Environmental and Reproductive Health Risk Factors for Lewy Body Dementia
Actual Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Environmental, occupational, reproductive health factors [1 year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California San Diego La Jolla California United States 92093

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Ece Bayram, MD, PhD, University of California, San Diego

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Ece Bayram, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT06005935
Other Study ID Numbers:
  • 805745
First Posted:
Aug 23, 2023
Last Update Posted:
Aug 23, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2023