Prodromal and Overt Parkinson's Disease Epidemiological Study in Brazil (PROBE-PD)

March 1, 2023 updated by: Artur Francisco Schuh, Hospital de Clinicas de Porto Alegre
Parkinson's Disease (PD) affects people universally, including all ethnic and socioeconomic groups, as a highly prevalent neurodegenerative disorder. However, there are several additional challenges for people living with PD in developing countries, especially those with low socioeconomic status. There is limited access to neurological care in Brazil due to an uneven distribution of neurologists and neurological facilities, which is more critical in the poorest regions. In addition, people in these vulnerable communities are more exposed to environmental pollution, including pesticides and metals used in agriculture and mining, respectively. Therefore, reliable data on the prevalence and incidence of PD in Brazil are essential to understand the proportion of this limited access to care for patients with PD, its burden in the region, and the potential role of environmental and lifestyle risk factors in PD. Unfortunately, the literature describes few epidemiological data on PD in Latin America, including Brazil, with an evident need for more information in their regions remarkably different. The investigators will carry out a population-based study in four municipalities in Brazil (Veranópolis-RS, Belém-PA, Jacobina-BA and Candangolândia-DF), comprising distinct communities in terms of ethnic groups, education levels, and environmental and lifestyle exposures, to portray the differences in Brazilian society. The present study will screen all people living in these regions aged 60 and over for parkinsonian symptoms and REM sleep behavior disorder (RBD). At least one neurologist will examine those selected to determine the diagnosis of PD or related disorders. The study also will evaluate a random sample of those individuals with a negative screen. Each participant selected after the screening will undergo clinical assessments and interview with the addition of a comprehensive questionnaire on clinical and sociodemographic data, prodromal symptoms, as well as lifestyle and environmental exposures, including occupational use and non-occupational use of pesticides and metals. An equal sample of blood and hair will be collected from individuals with PD and controls. The study will determine the prevalence of PD and related disorders in these distinct communities. An exploratory analysis also will be performed to determine the association between PD and each variable investigated.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Detailed Description:

This project proposes to evaluate the prevalence of PD and other parkinsonian syndromes in four regions of Brazil. Additionally, the incidence of PD and conversion of premotor symptoms into parkinsonian syndromes will be investigated in a 5-year cohort in a population-based sample in the southern region country. The investigators will also perform an exploratory analysis to assess the effect of environmental and lifestyle risk factors on PD.

Primary Purpose:

To determine the prevalence of Parkinson's disease and other Parkinson's syndromes in population-based samples of people aged 60 and over in the cities of Veranópolis (RS), Belém (PA), Jacobina (BA), and the administrative region of Candangolândia (DF).

Secondary Objective:

For all four regions studied:

To determine the overall prevalence and age- and sex-adjusted prevalence of Parkinson's disease; To determine the prevalence of other forms of parkinsonism (atypical, drug and vascular parkinsonism); To determine the prevalence of pre-motor symptoms of Parkinson's disease (REM sleep behavior disorder (RBD), constipation, hyposmia, subtle voice changes, depression in a sample of elderly individuals) To assess the association between Parkinson's disease and exposure to environmental factors: caffeine, tobacco, alcohol, pesticides, herbicides and other environmental toxicants; To evaluate the association between Parkinson's disease and biochemical and molecular biomarkers in peripheral fluids. The biological markers will be uric acid, iron, ferritin, transferrin and heavy metals;

Data Analysis Methodology:

The investigators will follow the STROBE statement for cross-sectional studies for data analysis and reporting of results for the study of prevalence and risk factors (Vandenbroucke et al. 2014). Data collection will be recorded in spreadsheets and digitally captured by REDCap tools (Harris et al. 2009) hosted at Hospital de Clínicas de Porto Alegre. For PD and other parkinsonian disorders, the aim will be to estimate: 1) crude prevalence, 2) age-specific prevalence, 3) gender-specific prevalence, and 4) age-adjusted prevalence rate.

Study Type

Observational

Enrollment (Anticipated)

8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Artur F Schuh-Schumacher, Dr.
  • Phone Number: +55 (51) 33598520
  • Email: aschuh@hcpa.edu.br

Study Contact Backup

Study Locations

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40301-110
        • Not yet recruiting
        • Hospital Geral Roberto Santos
        • Contact:
        • Contact:
    • DF
    • Pará
      • Belém, Pará, Brazil, 66050-160
        • Recruiting
        • Instituto de Ciências da Saúde
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Bruno L Santos-Lobato, MD, PhD
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90410-000
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:
          • Artur F Schuh-Schumacher, MD, PhD
          • Phone Number: +55 (51) 998239332
          • Email: aschuh@hcpa.edu.br
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population-based observational study to identify parkinsonian syndromes in four Brazilian cities: (1) Veranópolis, located in southern Brazil, with 25,936 inhabitants and an HDI of 0.773; (2) the insular portion of Belém (Ilha do Mosqueiro - Sucurijuquara and Furo das Marinhas Districts, Ilha do Outeiro - District of Fama, Combu and Cotijuba Islands), in the Amazon, Northern Brazil, with 15,469 inhabitants and an HDI of 0.573; (3) Candangolândia, in the Center-West of Brazil, with 16,196 inhabitants and an HDI of 0.852; and (4) Jacobina, in the Northeast of Brazil, with 80,635 inhabitants and an HDI of 0,649. All are small to medium-sized communities from different Brazilian regions, with different ethnic and socioeconomic compositions, which capture part of the country's diversity.

Description

Inclusion Criteria:

  • 60 years of age or older;
  • Permanent residence in Veranópolis, Candangolândia, Jacobina or Islands of Belém.

Exclusion Criteria:

  • Under 60 years of age
  • Not have permanent residence in Veranópolis, Candangolândia, Jacobina or Islands of Belém.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of parkinsonian syndrome and Parkinson's disease
Time Frame: The estimated time to apply Tanner and REM sleep behavior disorder (RBD) questionnaire for each study participant will be 10-15 minutes. Clinical assessment, questionnaire response, and blood and hair collection will take approximately 1.5 hours.
All people aged 60 and over will be screened for parkinsonian symptoms by the Tanner questionnaire (composed of 10 yes or no questions about motor signs). In addition, a questionnaire (RBD1Q) will be applied, consisting of one question that assesses REM sleep behavior disorder (RBD). The selected participants will undergo clinical assessments and interview with the aid of a comprehensive questionnaire on clinical and sociodemographic data, prodromal symptoms, as well as environmental and lifestyle exposures, including occupational and non-occupational use of pesticides and metals. A neurologist dedicated to Movement Disorders will diagnose parkinsonian syndrome based on the presence of bradykinesia plus rigidity or rest tremor and PD diagnosis based on the MDS Diagnostic Criteria. We will calculate for each region the (1) crude prevalence, (2) age-specific prevalence, (3) gender-specific prevalence, and (4) age-adjusted prevalence rate.
The estimated time to apply Tanner and REM sleep behavior disorder (RBD) questionnaire for each study participant will be 10-15 minutes. Clinical assessment, questionnaire response, and blood and hair collection will take approximately 1.5 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of secondary parkinsonisms, atypical parkinsonian syndromes, subtle parkinsonism of uncertain significance, suspected REM sleep behavior disorder
Time Frame: The neurological assessment and application of the MDS-UPDRS for each study participant is estimated to take 10 to 15 minutes. Clinical and neurological assessment, questionnaire response and blood and hair collection will take approximately 1.5 hours.
Participants selected in the screening will be evaluated by a neurologist dedicated to Movement Disorders with the aim of identifying any neurological condition other than parkinsonian syndrome, from a neurological assessment and application of the MDS-UPDRS.
The neurological assessment and application of the MDS-UPDRS for each study participant is estimated to take 10 to 15 minutes. Clinical and neurological assessment, questionnaire response and blood and hair collection will take approximately 1.5 hours.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDS - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time Frame: The estimated time to apply the MDS-UPDRS will be 30 minutes.
The UPDRS scale refers to Unified Parkinson Disease Rating Scale. It is a rating tool designed to assess the course of Parkinson's disease progression in patients. Each rating ranges from 0 to 4. The total score is between 0 and 108, the sum of 27 observation scores.
The estimated time to apply the MDS-UPDRS will be 30 minutes.
REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)
Time Frame: The estimated time to apply the REM Sleep Behavior Disorder Screening Questionnaire will be 30 minutes.
A single-question screen for Idiopathic rapid eye movement (REM) Sleep Behavior Disorder (RBD).
The estimated time to apply the REM Sleep Behavior Disorder Screening Questionnaire will be 30 minutes.
Montreal Cognitive Assessment (MoCA)
Time Frame: The estimated time to apply the Montreal Cognitive Assessment (MoCA) will be 10 minutes.
The MoCA is a cognitive screening test designed to assist Health Professionals in the detection of mild cognitive impairment. Scores range from 0-30.
The estimated time to apply the Montreal Cognitive Assessment (MoCA) will be 10 minutes.
Beck Depression Inventory (BDI-II)
Time Frame: The estimated time to apply the Beck Depression Inventory (BDI-II) will be 10 minutes.
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression).
The estimated time to apply the Beck Depression Inventory (BDI-II) will be 10 minutes.
Environmental exposure questionnaire
Time Frame: The estimated time to apply the Environmental exposure questionnaire will be 30 minutes.
The questionnaire assess the following exposures: specific medications, tobacco, alcohol, soda, black tea, source of drinking water, trauma, occupation, heavy metals, pesticides and fish intake.
The estimated time to apply the Environmental exposure questionnaire will be 30 minutes.
Sociodemographic questionnaire
Time Frame: The estimated time to apply the sociodemographic questionnaire will be 30 minutes.
Clinical and Sociodemographic Assessment Questionnaire assess sociodemographic information, which includes age, gender, family history, smoking, exposure to pesticides, comorbidities, medications in use, history of falls.
The estimated time to apply the sociodemographic questionnaire will be 30 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Michael J. Fox Foundation for Parkinson's Research

Investigators

  • Principal Investigator: Artur F Schuh-Schumacher, Dr., Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2021

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MJFF-020850

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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