Clinical trial NCT05677529: Prodromal and Overt Parkinson's Disease Epidemiological Study in Brazil
Official title: Prodromal and Overt Parkinson's Disease Epidemiological Study in Brazil
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2023-01-10
Enrollment: 8000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of parkinsonian syndrome and Parkinson's disease
timeFrame: 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:
measure: Prevalence of secondary parkinsonisms, atypical parkinsonian syndromes, subtle parkinsonism of uncertain significance, suspected REM sleep behavior disorder
timeFrame: 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:
measure: MDS - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: The estimated time to apply the MDS-UPDRS will be 30 minutes.
measure: REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)
timeFrame: The estimated time to apply the REM Sleep Behavior Disorder Screening Questionnaire will be 30 minutes.
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: The estimated time to apply the Montreal Cognitive Assessment (MoCA) will be 10 minutes.
measure: Beck Depression Inventory (BDI-II)
timeFrame: The estimated time to apply the Beck Depression Inventory (BDI-II) will be 10 minutes.
measure: Environmental exposure questionnaire
timeFrame: The estimated time to apply the Environmental exposure questionnaire will be 30 minutes.
measure: Sociodemographic questionnaire
timeFrame: The estimated time to apply the sociodemographic questionnaire will be 30 minutes.
Locations:
city: Salvador
country: Brazil
facility: Hospital Geral Roberto Santos
state: Bahia
city: Brasília
country: Brazil
facility: Hospital Sírio Libanês
state: DF
city: Belém
country: Brazil
facility: Instituto de Ciências da Saúde
state: Pará
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Artur F Schuh-Schumacher, Dr.
role: PRINCIPAL_INVESTIGATOR
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