Parkinson DiseasePROBE-PDNCT05677529
Prodromal and Overt Parkinson's Disease Epidemiological Study in Brazil
An observational study of Parkinson Disease and Parkinsonism, run by Hospital de Clinicas de Porto Alegre at 4 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Parkinsonism
- How many people
- 8,000 participants
- Where
- 4 sitesBrazil
- Study dates
- 30 Apr 2021to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 60 years of age or older;
- Permanent residence in Veranópolis, Candangolândia, Jacobina or Islands of Belém.
Who cannot join
- Under 60 years of age
- Not have permanent residence in Veranópolis, Candangolândia, Jacobina or Islands of Belém.
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites, 4 recruiting
- Recruiting
Instituto de Ciências da Saúde
Belém, Pará, 66050-160
Lane V Krejcová, PhD, +55 (91) 988995477, lanekrejcova@gmail.com
Juliana S Duarte, MSc, +55 (91) 996254382, julianadsantosduarte@gmail.com
- Recruiting
Hospital Sírio Libanês
Brasília, Federal District, 70200730
Pedro R de Paula Brandão, MD, PhD, +55 (61) 92264197, pedrobrandão.neurologia@gmail.com
Simoneide S Titze de Almeida, PhD, +55 (61) 984629221, simoneide.silva@gmail.com
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90410-000
Artur F Schuh-Schumacher, MD, PhD, +55 (51) 998239332, aschuh@hcpa.edu.br
Gabriela M Pereira, Phd Student, +55 (54) 984048164, gabpereira@hcpa.edu.br
- Not yet recruiting
Hospital Geral Roberto Santos
Salvador, Estado de Bahia, 40301-110
Guilherme T Valenca, MD, PhD, +55 (71) 997228550, gtvalenca@hotmail.com
Isabelle JW Oliveira, MD, +55 (71) 993554498, ijwoliveira@gmail.com
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Prodromal Symptoms, Neurodegenerative Diseases, REM Sleep Behavior Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start30 Apr 2021
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Artur Francisco Schuh, Hospital de Clinicas de Porto Alegre
- Investigators
- Artur F Schuh-Schumacher, Dr., Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677529
- Sponsor's protocol ID
- MJFF-020850
- Acronym
- PROBE-PD
- Status last verified
- Mar 2023
- First submitted
- 10 Aug 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barbosa MT, Caramelli P, Maia DP, Cunningham MC, Guerra HL, Lima-Costa MF, Cardoso F. Parkinsonism and Parkinson's disease in the elderly: a community-based survey in Brazil (the Bambui study). Mov Disord. 2006 Jun;21(6):800-8. doi: 10.1002/mds.20806.
PubMed 16482566Ball N, Teo WP, Chandra S, Chapman J. Parkinson's Disease and the Environment. Front Neurol. 2019 Mar 19;10:218. doi: 10.3389/fneur.2019.00218. eCollection 2019.
PubMed 30941085Berg D, Postuma RB, Adler CH, Bloem BR, Chan P, Dubois B, Gasser T, Goetz CG, Halliday G, Joseph L, Lang AE, Liepelt-Scarfone I, Litvan I, Marek K, Obeso J, Oertel W, Olanow CW, Poewe W, Stern M, Deuschl G. MDS research criteria for prodromal Parkinson's disease. Mov Disord. 2015 Oct;30(12):1600-11. doi: 10.1002/mds.26431.
PubMed 26474317Beck AT, Steer RA, Carbin MG. Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical Psychology Review. 1º de janeiro de 1988;8(1):77-100.
Bloem BR, Okun MS, Klein C. Parkinson's disease. Lancet. 2021 Jun 12;397(10291):2284-2303. doi: 10.1016/S0140-6736(21)00218-X. Epub 2021 Apr 10.
PubMed 33848468Bovolenta TM, de Azevedo Silva SM, Arb Saba R, Borges V, Ferraz HB, Felicio AC. Systematic Review and Critical Analysis of Cost Studies Associated with Parkinson's Disease. Parkinsons Dis. 2017;2017:3410946. doi: 10.1155/2017/3410946. Epub 2017 Mar 5.
PubMed 28357150Caldas ED, Jardim AN. Exposure to toxic chemicals in the diet: is the Brazilian population at risk? J Expo Sci Environ Epidemiol. 2012 Jan-Feb;22(1):1-15. doi: 10.1038/jes.2011.35. Epub 2011 Oct 12.
PubMed 21989502Consensus statement on the definition of orthostatic hypotension, pure autonomic failure, and multiple system atrophy. J Neurol Sci. 1996 Dec;144(1-2):218-9. No abstract available.
PubMed 8994128Elbaz A, Carcaillon L, Kab S, Moisan F. Epidemiology of Parkinson's disease. Rev Neurol (Paris). 2016 Jan;172(1):14-26. doi: 10.1016/j.neurol.2015.09.012. Epub 2015 Dec 21.
PubMed 26718594GBD 2016 Parkinson's Disease Collaborators. Global, regional, and national burden of Parkinson's disease, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):939-953. doi: 10.1016/S1474-4422(18)30295-3. Epub 2018 Oct 1.
PubMed 30287051Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.
PubMed 19025984Guigoz Y. The Mini Nutritional Assessment (MNA) review of the literature--What does it tell us? J Nutr Health Aging. 2006 Nov-Dec;10(6):466-85; discussion 485-7.
PubMed 17183419Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686Heinzel S, Berg D, Gasser T, Chen H, Yao C, Postuma RB; MDS Task Force on the Definition of Parkinson's Disease. Update of the MDS research criteria for prodromal Parkinson's disease. Mov Disord. 2019 Oct;34(10):1464-1470. doi: 10.1002/mds.27802. Epub 2019 Aug 14.
PubMed 31412427Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
PubMed 1798888
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prodromal and Overt Parkinson's Disease Epidemiological Study in Brazil
- ClinicalTrials.gov ID
- NCT05677529
- Acronym / sponsor ID
- PROBE-PD / MJFF-020850
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 10 Jan 2023 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 60 years of age or older;
- Permanent residence in Veranópolis, Candangolândia, Jacobina or Islands of Belém.
Key exclusion criteria (2 listed)
- Under 60 years of age
- Not have permanent residence in Veranópolis, Candangolândia, Jacobina or Islands of Belém.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Background: PubMed 16482566Barbosa MT, Caramelli P, Maia DP, Cunningham MC, Guerra HL, Lima-Costa MF, Cardoso F. Parkinsonism and Parkinson's disease in the elderly: a community-based survey in Brazil (the Bambui study). Mov Disord. 2006 Jun;21(6):800-8. doi: 10.1002/mds.20806.
- Background: PubMed 30941085Ball N, Teo WP, Chandra S, Chapman J. Parkinson's Disease and the Environment. Front Neurol. 2019 Mar 19;10:218. doi: 10.3389/fneur.2019.00218. eCollection 2019.
- Background: PubMed 26474317Berg D, Postuma RB, Adler CH, Bloem BR, Chan P, Dubois B, Gasser T, Goetz CG, Halliday G, Joseph L, Lang AE, Liepelt-Scarfone I, Litvan I, Marek K, Obeso J, Oertel W, Olanow CW, Poewe W, Stern M, Deuschl G. MDS research criteria for prodromal Parkinson's disease. Mov Disord. 2015 Oct;30(12):1600-11. doi: 10.1002/mds.26431.
- BackgroundBeck AT, Steer RA, Carbin MG. Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical Psychology Review. 1º de janeiro de 1988;8(1):77-100.
- Background: PubMed 33848468Bloem BR, Okun MS, Klein C. Parkinson's disease. Lancet. 2021 Jun 12;397(10291):2284-2303. doi: 10.1016/S0140-6736(21)00218-X. Epub 2021 Apr 10.
- Background: PubMed 28357150Bovolenta TM, de Azevedo Silva SM, Arb Saba R, Borges V, Ferraz HB, Felicio AC. Systematic Review and Critical Analysis of Cost Studies Associated with Parkinson's Disease. Parkinsons Dis. 2017;2017:3410946. doi: 10.1155/2017/3410946. Epub 2017 Mar 5.
- Background: PubMed 21989502Caldas ED, Jardim AN. Exposure to toxic chemicals in the diet: is the Brazilian population at risk? J Expo Sci Environ Epidemiol. 2012 Jan-Feb;22(1):1-15. doi: 10.1038/jes.2011.35. Epub 2011 Oct 12.
- Background: PubMed 8994128Consensus statement on the definition of orthostatic hypotension, pure autonomic failure, and multiple system atrophy. J Neurol Sci. 1996 Dec;144(1-2):218-9. No abstract available.
- Background: PubMed 26718594Elbaz A, Carcaillon L, Kab S, Moisan F. Epidemiology of Parkinson's disease. Rev Neurol (Paris). 2016 Jan;172(1):14-26. doi: 10.1016/j.neurol.2015.09.012. Epub 2015 Dec 21.
- Background: PubMed 30287051GBD 2016 Parkinson's Disease Collaborators. Global, regional, and national burden of Parkinson's disease, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):939-953. doi: 10.1016/S1474-4422(18)30295-3. Epub 2018 Oct 1.
- Background: PubMed 19025984Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.
- Background: PubMed 17183419Guigoz Y. The Mini Nutritional Assessment (MNA) review of the literature--What does it tell us? J Nutr Health Aging. 2006 Nov-Dec;10(6):466-85; discussion 485-7.
- Câncer, Instituto Nacional D. O. 2015. "Posicionamento Do INCA Acerca Dos Agrotóxicos." INCA Brasília-DFLink provided by the sponsor.
- 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.Link provided by the sponsor.
- Carneiro, Fernando Ferreira, and Others. 2015. Dossiê ABRASCO: Um Alerta Sobre Os Impactos Dos Agrotóxicos Na Saúde. EPSJV/Expressão Popular.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Artur F Schuh-Schumacher, Dr. principal investigator
Hospital de Clinicas de Porto Alegre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Parkinsonism, run by Hospital de Clinicas de Porto Alegre at 4 sites in Brazil.
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: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Artur F Schuh-Schumacher, Dr. (+55 (51) 33598520, aschuh@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05677529, which also lists 38 linked publications.
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 2 Mar 2023.