Motor, Non-motor and Genetic Determinants of Progression in Parkinson's Disease: A Mexican Multicenter Cohort Study

Parkinson's Disease Clinical Trial

— ReMePARK  

Official title:

Motor, Non-motor and Genetic Determinants of Progression and Complications in Parkinson's Disease: A Multicenter Cohort Study in Mexican Population (ReMePArk)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865877
• Other study ID #: INNN 35/12
• Secondary ID: 182133
• Status: Completed
• Phase: N/A
• First received: May 28, 2013
• Last updated: March 1, 2017
• Start date: August 2012
• Est. completion date: August 2016

Study information

• Verified date: March 2017
• Source: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease Progression
• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
Mexico	Hospital Civil de Guadalajara	Guadalajara	Jalisco
Mexico	Hospital Regional #1	Mérida	Yucatán
Mexico	Hospital General de México	Mexico City
Mexico	Instituto Nacional de Neurología y Neurocirugía	Mexico City
Mexico	Hospital Universitario	Monterrey	Nuevo León
Mexico	Hospital Universitario	San Luis Potosí
Mexico	Hospital General de Zacatecas	Zacatecas

Sponsors (2)

Lead Sponsor	Collaborator
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez	National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

Cervantes Arriaga A, Rodríguez Violante M, Camacho Ordóñez A, González Latapi P, López Ruiz M, Estrada Bellmann I, Zúñiga Ramírez C, Otero Cerdeira E. [Time from motor symptoms onset to diagnosis of Parkinson's disease in Mexico]. Gac Med Mex. 2014 Dec;15 — View Citation

Cervantes-Arriaga A, Rodríguez-Violante M, López-Ruiz M, Estrada-Bellmann I, Zuñiga-Ramírez C, Otero-Cerdeira E, Camacho-Ordoñez A, González-Latapi P, Morales-Briceño H, Martínez-Ramírez D. [Profile characterization of Parkinson's disease in Mexico: ReMeP — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess the change in prevalence of neuropsychiatric symptoms over time	Prevalence and incidence of depression, apathy, cognitive decline, psychosis and impulse control disorder will be determined.	Every 12 months for 2 years
Primary	To assess motor scale change over time	Motor symptoms will be assessed by proper and validated motor scales; also minimal clinically important change will be determined.	Every 6 months for 2 years
Secondary	To assess non-motor symptoms over time	Non-motor symptoms will be assessed using proper validated scales. Frequency and severity will be recorded.	Every 6 months for 2 years
Secondary	To assess quality of life change over time.	Health-related quality of life will be assessed with proper validated clinimetric instruments.	Every 6 months for 2 years
Secondary	To assess caregiver burden as disease progresses	Caregiver burden will be assessed by proper validated scales.	Every 12 months for 2 years

External Links

•   Instituto Nacional de Neurología y Neurocirugía