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Completed

NCT Number: NCT01865877

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Disease Attributes Disease Progression Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Synucleinopathies

Age range

20 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Civil de Guadalajara, Guadalajara, Jalisco, Mexico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To assess motor scale change over time

    Time frame: 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 outcomes

  1. To assess non-motor symptoms over time

    Time frame: Every 6 months for 2 years

    Non-motor symptoms will be assessed using proper validated scales. Frequency and severity will be recorded.

  2. To assess quality of life change over time.

    Time frame: Every 6 months for 2 years

    Health-related quality of life will be assessed with proper validated clinimetric instruments.

  3. To assess caregiver burden as disease progresses

    Time frame: Every 12 months for 2 years

    Caregiver burden will be assessed by proper validated scales.

Other outcomes

  1. To assess the change in prevalence of neuropsychiatric symptoms over time

    Time frame: Every 12 months for 2 years

    Prevalence and incidence of depression, apathy, cognitive decline, psychosis and impulse control disorder will be determined.

Sponsors and collaborators

Lead sponsor

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Other

Collaborators

  • National Council of Science and Technology, Mexico

Registry information

Official study title

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

Acronym: ReMePARK

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 31, 2013
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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