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

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT01865877
• Lead Sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-28
• Study First Posted: 2013-05-31
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess motor scale change over time	Every 6 months for 2 years	Motor symptoms will be assessed by proper and validated motor scales; also minimal clinically important change will be determined.

Secondary Outcome Measures

Name	Time	Method
To assess caregiver burden as disease progresses	Every 12 months for 2 years	Caregiver burden will be assessed by proper validated scales.
To assess quality of life change over time.	Every 6 months for 2 years	Health-related quality of life will be assessed with proper validated clinimetric instruments.
To assess non-motor symptoms over time	Every 6 months for 2 years	Non-motor symptoms will be assessed using proper validated scales. Frequency and severity will be recorded.

Trial Locations

Locations (6)

Hospital Universitario; 🇲🇽 San Luis Potosí, Mexico

Hospital General de México; 🇲🇽 Mexico City, Mexico

Instituto Nacional de Neurología y Neurocirugía; 🇲🇽 Mexico City, Mexico

Hospital General de Zacatecas; 🇲🇽 Zacatecas, Mexico

Hospital Civil de Guadalajara; 🇲🇽 Guadalajara, Jalisco, Mexico

Hospital Regional #1; 🇲🇽 Mérida, Yucatán, Mexico