Prodromal and Overt Parkinson's Disease Epidemiological Study in Brazil

NCT05677529 | Unknown

• 1 other identifier: MJFF-020850
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Parkinson Disease; Parkinsonism

Keywords

Parkinson's disease; Prodromal symptoms; Neurodegenerative disorder; REM Sleep Behavior Disorder; Primary parkinsonism; Epidemiology; Health Disparity, Minority and Vulnerable Populations; Risk Factors; Parkinsonian Disorders; Prevalence

Outcome Measures

Primary Outcomes (1)

• Prevalence of parkinsonian syndrome and Parkinson's disease

  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 Outcomes (1)

• Prevalence of secondary parkinsonisms, atypical parkinsonian syndromes, subtle parkinsonism of uncertain significance, suspected REM sleep behavior disorder

  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 Outcomes (6)

• MDS - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  The estimated time to apply the MDS-UPDRS will be 30 minutes.

• REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)

  The estimated time to apply the REM Sleep Behavior Disorder Screening Questionnaire will be 30 minutes.

• Montreal Cognitive Assessment (MoCA)

  The estimated time to apply the Montreal Cognitive Assessment (MoCA) will be 10 minutes.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (4)

Hospital Geral Roberto Santos

Salvador, Estado de Bahia, 40301-110, Brazil

NOT YET RECRUITING

Hospital Sírio Libanês

Brasília, Federal District, 70200730, Brazil

RECRUITING

Instituto de Ciências da Saúde

Belém, Pará, 66050-160, Brazil

RECRUITING

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90410-000, Brazil

RECRUITING

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Related Links

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Biospecimen

Retention: SAMPLES WITH DNA

Hair and blood samples will be collected from a subsample of volunteers screened positive and negative after presential neurological consultation.

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Prodromal Symptoms; Neurodegenerative Diseases; REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Artur F Schuh-Schumacher, Dr.

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Artur F Schuh-Schumacher, Dr.

CONTACT

+55 (51) 33598520; aschuh@hcpa.edu.br

Gabriela M Pereira, Phd Student

CONTACT

+55 (51) 33085605; gabpereira@hcpa.edu.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: January 10, 2023
• Study Start: April 30, 2021
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 2, 2023

Record last verified: 2023-03

Locations

BR (4)