Clinical trial NCT06005935: Environmental and Reproductive Health Risk for Lewy Body Dementia
Official title: Sex-Specific Environmental and Reproductive Health Risk Factors for Lewy Body Dementia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lewy Body Dementia
Parkinson Disease Dementia
Dementia With Lewy Bodies
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: The Lewy Body Dementia Association (LBDA)
First posted: 2023-08-23
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Environmental, occupational, reproductive health factors
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Ece Bayram, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: