NCT01865877

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

4 years

First QC Date

May 28, 2013

Last Update Submit

March 1, 2017

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseMotorNon-motorProgressionComplications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • To assess non-motor symptoms over time

    Every 6 months for 2 years

  • To assess quality of life change over time.

    Every 6 months for 2 years

  • To assess caregiver burden as disease progresses

    Every 12 months for 2 years

Other Outcomes (1)

  • To assess the change in prevalence of neuropsychiatric symptoms over time

    Every 12 months for 2 years

Study Arms (1)

PD Cohort

Subjects diagnosed with Parkinson's disease

Eligibility Criteria

Age20 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects diagnosed with idiopathic or genetic Parkinson's disease attending any of the participant sites in Mexico.

You may qualify if:

  • 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

You may not qualify if:

  • Severe comorbidity that may limit proper neurological evaluation as judged by the investigator
  • Subjects with atypical or secondary parkinsonism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hospital Civil de Guadalajara

Guadalajara, Jalisco, 44280, Mexico

Location

Hospital General de México

Mexico City, Mexico City, 06726, Mexico

Location

Instituto Nacional de Neurología y Neurocirugía

Mexico City, Mexico City, 14269, Mexico

Location

Hospital Universitario

Monterrey, Nuevo León, 64460, Mexico

Location

Hospital Universitario

San Luis Potosí City, San Luis Potosí, 23000, Mexico

Location

Hospital Regional #1

Mérida, Yucatán, 97134, Mexico

Location

Hospital General de Zacatecas

Zacatecas City, Zacatecas, 11340, Mexico

Location

Related Publications (2)

  • 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.

    PMID: 24108335RESULT

  • 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.

    PMID: 25643785RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Serum and/or saliva

MeSH Terms

Conditions

Parkinson DiseaseDisease Progression

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amin Cervantes-Arriaga, MD,MSc

    Instituto Nacional de Neurología y Neurocirugía

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

May 28, 2013

First Posted

May 31, 2013

Study Start

August 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

ME(7)