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Trial record 13 of 158 for:    genetics AND Parkinson's disease

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

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ClinicalTrials.gov Identifier: NCT01865877
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Amin Cervantes-Arriaga, 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.


Condition or disease
Parkinson's Disease

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 : Observational [Patient Registry]
Actual Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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 Start Date : August 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Group/Cohort
PD Cohort
Subjects diagnosed with Parkinson's disease



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Biospecimen Retention:   Samples With DNA
Serum and/or saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects diagnosed with idiopathic or genetic Parkinson's disease attending any of the participant sites in Mexico.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865877


Locations
Mexico
Hospital Civil de Guadalajara
Guadalajara, Jalisco, Mexico, 44280
Hospital Universitario
Monterrey, Nuevo León, Mexico, 64460
Hospital Regional #1
Mérida, Yucatán, Mexico, 97134
Hospital General de México
Mexico City, Mexico, 06726
Instituto Nacional de Neurología y Neurocirugía
Mexico City, Mexico, 14269
Hospital Universitario
San Luis Potosí, Mexico, 23000
Hospital General de Zacatecas
Zacatecas, Mexico, 11340
Sponsors and Collaborators
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
National Council of Science and Technology, Mexico
Investigators
Principal Investigator: Amin Cervantes-Arriaga, MD,MSc Instituto Nacional de Neurología y Neurocirugía

Additional Information:
Publications of Results:
Responsible Party: Amin Cervantes-Arriaga, MD, MSc, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
ClinicalTrials.gov Identifier: NCT01865877     History of Changes
Other Study ID Numbers: INNN 35/12
182133 ( Other Grant/Funding Number: CONACyT FOSSIS 182133 )
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by Amin Cervantes-Arriaga, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez:
Parkinson's disease
Motor
Non-motor
Progression
Complications

Additional relevant MeSH terms:
Parkinson Disease
Disease Progression
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Disease Attributes
Pathologic Processes