Prodromal and Overt Parkinson's Disease Epidemiological Study in Brazil

Parkinson Disease Clinical Trial

— PROBE-PD  

Official title:

Prodromal and Overt Parkinson's Disease Epidemiological Study in Brazil

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05677529
• Other study ID #: MJFF-020850
• Status: Recruiting
• Start date: April 30, 2021
• Est. completion date: March 2025

Study information

• Verified date: March 2023
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Artur F Schuh-Schumacher, Dr.
• Phone: +55 (51) 33598520
• Email: aschuh[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinsonian Disorders
• Parkinsonism

Locations

Country	Name	City	State
Brazil	Instituto de Ciências da Saúde	Belém	Pará
Brazil	Hospital Sírio Libanês	Brasília	DF
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Geral Roberto Santos	Salvador	Bahia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

Brazil, 

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MDS - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	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.
Other	REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)	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.
Other	Montreal Cognitive Assessment (MoCA)	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.
Other	Beck Depression Inventory (BDI-II)	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.
Other	Environmental exposure questionnaire	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.
Other	Sociodemographic questionnaire	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.
Primary	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	Prevalence of secondary parkinsonisms, atypical parkinsonian syndromes, subtle parkinsonism of uncertain significance, suspected REM sleep behavior disorder	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.

External Links

•   Câncer, Instituto Nacional D. O. 2015. "Posicionamento Do INCA Acerca Dos Agrotóxicos." INCA Brasília-DF
•   Carmo, Marina Araujo Trajano do, Luiz Claudio Meirelles, and Ariany Oliveira Santos Nicolich. 2018. Análise do Programa de Análise de Resíduos de Agrotóxicos em Alimentos (PARA) no período de 2010 a 2016 no Brasil. ABRASCO.
•   Carneiro, Fernando Ferreira, and Others. 2015. Dossiê ABRASCO: Um Alerta Sobre Os Impactos Dos Agrotóxicos Na Saúde. EPSJV/Expressão Popular.