- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01865877
Motor, Non-motor and Genetic Determinants of Progression in Parkinson's Disease: A Mexican Multicenter Cohort Study (ReMePARK)
Motor, Non-motor and Genetic Determinants of Progression and Complications in Parkinson's Disease: A Multicenter Cohort Study in Mexican Population (ReMePArk)
The objective of the study is to assess the effect of motor, non-motor and genetic factors on the progression of Parkinson's disease as well as its impact on complications rates.
A large sample of Mexican subjects with Parkinson's disease attending several referral centers will be included.
Data collected will include disease severity and motor scales, non-motor scales as well as genotyping for monogenic forms of the disease.
Assessments will be performed every 6 months for two years.
Study Overview
Status
Conditions
Detailed Description
Demographic and clinical data will be collected after obtaining a signed informed consent.
Recruitment will be competitive. Data collected includes age, gender, motor phenotype, age at onset, age at diagnosis, smoking history, family history, antiparkinsonic treatment, other treatments and a complete neurological evaluation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Mexico City, Mexico, 06726
- Hospital General de México
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Mexico City, Mexico, 14269
- Instituto Nacional de Neurologia y Neurocirugia
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San Luis Potosí, Mexico, 23000
- Hospital Universitario
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Zacatecas, Mexico, 11340
- Hospital General de Zacatecas
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Jalisco
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Guadalajara, Jalisco, Mexico, 44280
- Hospital Civil de Guadalajara
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- Hospital Universitario
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Yucatán
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Mérida, Yucatán, Mexico, 97134
- Hospital Regional #1
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of Parkinson's disease by the United Kingdom Parkinson's disease Society Brain Bank Criteria
- Any gender
- Any Hoehn and Yahr stage
- Written informed consent
Exclusion Criteria:
- Severe comorbidity that may limit proper neurological evaluation as judged by the investigator
- Subjects with atypical or secondary parkinsonism
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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PD Cohort
Subjects diagnosed with Parkinson's disease
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess motor scale change over time
Time Frame: Every 6 months for 2 years
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Motor symptoms will be assessed by proper and validated motor scales; also minimal clinically important change will be determined.
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Every 6 months for 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess non-motor symptoms over time
Time Frame: Every 6 months for 2 years
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Non-motor symptoms will be assessed using proper validated scales.
Frequency and severity will be recorded.
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Every 6 months for 2 years
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To assess quality of life change over time.
Time Frame: Every 6 months for 2 years
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Health-related quality of life will be assessed with proper validated clinimetric instruments.
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Every 6 months for 2 years
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To assess caregiver burden as disease progresses
Time Frame: Every 12 months for 2 years
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Caregiver burden will be assessed by proper validated scales.
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Every 12 months for 2 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the change in prevalence of neuropsychiatric symptoms over time
Time Frame: Every 12 months for 2 years
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Prevalence and incidence of depression, apathy, cognitive decline, psychosis and impulse control disorder will be determined.
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Every 12 months for 2 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Amin Cervantes-Arriaga, MD,MSc, Instituto Nacional de Neurologia y Neurocirugia
Publications and helpful links
General Publications
- Cervantes-Arriaga A, Rodriguez-Violante M, Lopez-Ruiz M, Estrada-Bellmann I, Zuniga-Ramirez C, Otero-Cerdeira E, Camacho-Ordonez A, Gonzalez-Latapi P, Morales-Briceno H, Martinez-Ramirez D. [Profile characterization of Parkinson's disease in Mexico: ReMePARK study]. Gac Med Mex. 2013 Sep-Oct;149(5):497-501. Spanish.
- Cervantes Arriaga A, Rodriguez Violante M, Camacho Ordonez A, Gonzalez Latapi P, Lopez Ruiz M, Estrada Bellmann I, Zuniga Ramirez C, Otero Cerdeira E. [Time from motor symptoms onset to diagnosis of Parkinson's disease in Mexico]. Gac Med Mex. 2014 Dec;150 Suppl 2:242-7. Spanish.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INNN 35/12
- 182133 (Other Grant/Funding Number: CONACyT FOSSIS 182133)
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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