Clinical trial NCT01865877: Motor, Non-motor and Genetic Determinants of Progression in Parkinson's Disease: A Mexican Multicenter Cohort Study
Official title: Motor, Non-motor and Genetic Determinants of Progression and Complications in Parkinson's Disease: A Multicenter Cohort Study in Mexican Population (ReMePArk)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Motor
Non-motor
Progression
Complications
Lead sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Sponsor class: OTHER
Collaborators: name: National Council of Science and Technology, Mexico
First posted: 2013-05-31
Enrollment: 550
Sex: ALL
Minimum age (years): 20
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnosed with idiopathic or genetic Parkinson's disease attending any of the participant sites in Mexico.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess motor scale change over time
timeFrame: Every 6 months for 2 years
Secondary outcomes:
measure: To assess non-motor symptoms over time
timeFrame: Every 6 months for 2 years
measure: To assess quality of life change over time.
timeFrame: Every 6 months for 2 years
measure: To assess caregiver burden as disease progresses
timeFrame: Every 12 months for 2 years
Other outcomes:
measure: To assess the change in prevalence of neuropsychiatric symptoms over time
timeFrame: Every 12 months for 2 years
Locations:
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario
state: Nuevo León
city: Mérida
country: Mexico
facility: Hospital Regional #1
state: Yucatán
city: Mexico City
country: Mexico
facility: Hospital General de México
city: Mexico City
country: Mexico
facility: Instituto Nacional de Neurología y Neurocirugía
city: San Luis Potosí
country: Mexico
facility: Hospital Universitario
city: Zacatecas
country: Mexico
facility: Hospital General de Zacatecas
Study officials:
affiliation: Instituto Nacional de Neurología y Neurocirugía
name: Amin Cervantes-Arriaga, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.