Environmental and Reproductive Health Risk for Lewy Body Dementia

NCT ID: NCT06005935

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lewy Body Dementia Parkinson Disease Dementia Dementia With Lewy Bodies

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Survey

Intervention Type 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

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.

Survey

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Lewy Body Dementia Association (LBDA)

UNKNOWN

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Ece Bayram

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ece Bayram, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California San Diego

La Jolla, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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805745

Identifier Type: -

Identifier Source: org_study_id

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