Pesticide-Induced ParkinsonismPest-PDNCT06420310
Pesticides and Parkinson´s Disease
An observational study of Pesticide-Induced Parkinsonism, run by Hospital Universitario de Burgos at 1 site in Spain.
Trial summary
The aim of this project is to study whether people exposed to pesticides have a higher risk of developing PD. We will perform an epidemiological study determining the presence of pesticides in urine and comparing signs traditionally associated with PD in early forms. Read more about this study
- Who is it for?
- Ages 45 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pesticide-Induced Parkinsonism
- What is being tested?
- exposure to pesticides
- How many people
- 260 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2024to 30 Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects not diagnosed with PD living in Burgos region
Who may be able to join
- Farmers exposed to pesticides for cases
- No work exposure to pesticides for controls
Who cannot join
- Subjects without signed consent form
- Neurological significant conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Burgos
Burgos, 09006
Esther Cubo, MD, +34947256533, mcubo@saludcastillayleon.es
About this study
Official title: Prevalence of Preclinical and Prodromal Parkinson´s Disease in Subjects Exposed to Pesticides
The aim of this project is to study whether people exposed to pesticides have a higher risk of developing PD. We will perform an epidemiological study determining the presence of pesticides in urine and comparing signs traditionally associated with PD in early forms.
Read the detailed description
Within different risk factors, pesticide exposure increases the risk of developing Parkinson's disease (PD) through epigenetic mechanisms by modifying the expression of genes related to PD and secondary mitochondrial dysfunction.We will conduct a cross-sectional prevalence study with cases (exposed to pesticides) and controls (not exposed to pesticides), randomly selecting 130 individuals in each group. Pesticide exposure will be determined through questionnaires.We will study the prevalence of preclinical and prodromal PD based on pesticide exposure, stratified by age and gender in the exposed, and non-exposed groups. Preclinical and prodromal PD will be assessed using: biological biomarkers and prodromal PD signs. Multivariate analyses will be employed to determine the risk of presenting early PD, adjusting for different clinical covariates. The results of this study will allow us to understand the early mechanisms associated with neurodegeneration and pesticides exposure.
- Conditions
- Pesticide-Induced Parkinsonism
- Being tested
- exposure to pesticides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure to pesticidesOther
based on work exposures to pesticides
| Study group | Role | What they receive |
|---|---|---|
| Cases | Subjects exposed to pesticides Receives: Other: exposure to pesticides | |
| Controls | Subjects without any exposure to pesticides Receives: Other: exposure to pesticides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prodromal PD
Early non motor symptoms
Measured: over the last year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Apr 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pesticide-Induced ParkinsonismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 260 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Burgos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Cubo, Hospital Universitario de Burgos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420310
- Sponsor's protocol ID
- GRS 2682/A1/2023
- Acronym
- Pest-PD
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Preclinical and Prodromal Parkinson´s Disease in Subjects Exposed to Pesticides
- ClinicalTrials.gov ID
- NCT06420310
- Acronym / sponsor ID
- Pest-PD / GRS 2682/A1/2023
- Conditions
- Pesticide-Induced Parkinsonism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Hospital Universitario de BurgosUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this project is to study whether people exposed to pesticides have a higher risk of developing PD. We will perform an epidemiological study determining the presence of pesticides in urine and comparing signs traditionally associated with PD in early forms.
Detailed description
Within different risk factors, pesticide exposure increases the risk of developing Parkinson's disease (PD) through epigenetic mechanisms by modifying the expression of genes related to PD and secondary mitochondrial dysfunction.We will conduct a cross-sectional prevalence study with cases (exposed to pesticides) and controls (not exposed to pesticides), randomly selecting 130 individuals in each group. Pesticide exposure will be determined through questionnaires.We will study the prevalence of preclinical and prodromal PD based on pesticide exposure, stratified by age and gender in the exposed, and non-exposed groups. Preclinical and prodromal PD will be assessed using: biological biomarkers and prodromal PD signs. Multivariate analyses will be employed to determine the risk of presenting early PD, adjusting for different clinical covariates. The results of this study will allow us to understand the early mechanisms associated with neurodegeneration and pesticides exposure.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: exposure to pesticidesSubjects exposed to pesticides |
| Controls | – | Other: exposure to pesticidesSubjects without any exposure to pesticides |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects not diagnosed with PD living in Burgos region
Key inclusion criteria (2 listed)
- Farmers exposed to pesticides for cases
- No work exposure to pesticides for controls
Key exclusion criteria (2 listed)
- Subjects without signed consent form
- Neurological significant conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exposure to pesticidesbased on work exposures to pesticides | Other | Cases, Controls |
Primary outcome
Prodromal PD
Time frame: over the last year
Early non motor symptoms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pesticide-Induced Parkinsonism, run by Hospital Universitario de Burgos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prodromal PD (time frame: over the last year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.