- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01502384
A Longitudinal Study in 1st Degree Relatives of Parkinson's Disease (PD) Patients
December 29, 2011 updated by: Tel-Aviv Sourasky Medical Center
This is a longitudinal study in healthy 1st degree relatives of patients with Parkinson's Disease (PD) carriers of a genetic mutation in genes that are known to increase the risk for PD.
The purpose of this study is to explore the association between genetic mutations in the known genes and early preclinical symptoms such as motor, sensory, autonomic, behavioral and cognitive functions.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tel Aviv, Israel
- Tel Aviv Sourasky Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy 1ST degree realtives of PD patients
Description
Inclusion Criteria:
- healthy 1ST degree relatives of PD patients with known genotype that participated in an earlier genetic study at the sourasky medical center.
Exclusion Criteria:
- subjects with cognitive decline by the parameters defined in DSM- IV
- subjects with psychiatric disorder
- subjects unable to sign a consent form
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
healthy relatives
healthy 1st degree relatives of PD patients
|
motor and cognitive functions
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Di Monte DA. The environment and Parkinson's disease: is the nigrostriatal system preferentially targeted by neurotoxins? Lancet Neurol. 2003 Sep;2(9):531-8. doi: 10.1016/s1474-4422(03)00501-5.
- Di Monte DA, Lavasani M, Manning-Bog AB. Environmental factors in Parkinson's disease. Neurotoxicology. 2002 Oct;23(4-5):487-502. doi: 10.1016/s0161-813x(02)00099-2.
- Huang Y, Cheung L, Rowe D, Halliday G. Genetic contributions to Parkinson's disease. Brain Res Brain Res Rev. 2004 Aug;46(1):44-70. doi: 10.1016/j.brainresrev.2004.04.007.
- Quik M. Smoking, nicotine and Parkinson's disease. Trends Neurosci. 2004 Sep;27(9):561-8. doi: 10.1016/j.tins.2004.06.008.
- Vila M, Przedborski S. Genetic clues to the pathogenesis of Parkinson's disease. Nat Med. 2004 Jul;10 Suppl:S58-62. doi: 10.1038/nm1068.
- von Bohlen und Halbach O, Schober A, Krieglstein K. Genes, proteins, and neurotoxins involved in Parkinson's disease. Prog Neurobiol. 2004 Jun;73(3):151-77. doi: 10.1016/j.pneurobio.2004.05.002.
- Farrer M, Stone J, Mata IF, Lincoln S, Kachergus J, Hulihan M, Strain KJ, Maraganore DM. LRRK2 mutations in Parkinson disease. Neurology. 2005 Sep 13;65(5):738-40. doi: 10.1212/01.wnl.0000169023.51764.b0.
- Wilk JB, Lash TL. Risk factor studies of age-at-onset in a sample ascertained for Parkinson disease affected sibling pairs: a cautionary tale. Emerg Themes Epidemiol. 2007 Apr 4;4:1. doi: 10.1186/1742-7622-4-1.
- Orr-Urtreger A, Shifrin C, Rozovski U, Rosner S, Bercovich D, Gurevich T, Yagev-More H, Bar-Shira A, Giladi N. The LRRK2 G2019S mutation in Ashkenazi Jews with Parkinson disease: is there a gender effect? Neurology. 2007 Oct 16;69(16):1595-602. doi: 10.1212/01.wnl.0000277637.33328.d8.
- Clark LN, Nicolai A, Afridi S, Harris J, Mejia-Santana H, Strug L, Cote LJ, Louis ED, Andrews H, Waters C, Ford B, Frucht S, Fahn S, Mayeux R, Ottman R, Marder K. Pilot association study of the beta-glucocerebrosidase N370S allele and Parkinson's disease in subjects of Jewish ethnicity. Mov Disord. 2005 Jan;20(1):100-3. doi: 10.1002/mds.20320.
- Thaler A, Ash E, Gan-Or Z, Orr-Urtreger A, Giladi N. The LRRK2 G2019S mutation as the cause of Parkinson's disease in Ashkenazi Jews. J Neural Transm (Vienna). 2009 Nov;116(11):1473-82. doi: 10.1007/s00702-009-0303-0.
- Mirelman A, Gurevich T, Giladi N, Bar-Shira A, Orr-Urtreger A, Hausdorff JM. Gait alterations in healthy carriers of the LRRK2 G2019S mutation. Ann Neurol. 2011 Jan;69(1):193-7. doi: 10.1002/ana.22165.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Anticipated)
June 1, 2015
Study Registration Dates
First Submitted
December 28, 2011
First Submitted That Met QC Criteria
December 29, 2011
First Posted (Estimate)
December 30, 2011
Study Record Updates
Last Update Posted (Estimate)
December 30, 2011
Last Update Submitted That Met QC Criteria
December 29, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-11-NG-0463
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson's Disease
-
EicOsis Human Health Inc.University of California, Davis; Michael J. Fox Foundation for Parkinson's...RecruitingParkinson's Disease (PD)United States
-
University of Kansas Medical CenterNot yet recruitingParkinson's Disease (PD)United States
-
AbbVieRecruiting
-
University Hospital Schleswig-HolsteinUniversity of Kiel; University of Cologne; University Hospital, Bonn; Philipps...Not yet recruitingParkinson's Disease (PD)
-
InvicroMerck Sharp & Dohme LLCRecruitingParkinson's Disease | Parkinson's Disease (PD) | Parkinson's Disease (Disorder)United States
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
Assistance Publique - Hôpitaux de ParisFrance Parkinson AssociationUnknownHealthy Controls | Parkinson's Disease With LRRK2 Mutation | Parkinson's Disease Without LRRK2 MutationFrance
-
Guangzhou Henovcom Bioscience Co. Ltd.Frontage Clinical Services, Inc.Active, not recruitingParkinson's Disease (PD)United States
-
Universitätsklinikum Hamburg-EppendorfUniversity of TwenteRecruitingParkinson's Disease | Deep Brain StimulationGermany
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
Clinical Trials on neurological examination
-
Vanderbilt University Medical CenterAllerganCompletedNervous System Diseases | Neurologic Manifestations | Muscular Diseases | Neuromuscular Manifestations | Muscle Hypertonia | Spasticity, Muscle | Muscle Spasticity | Musculoskeletal Disease | Signs and SymptomsUnited States
-
Vanderbilt University Medical CenterAllerganCompletedPrevalence of Comorbid Spasticity and Urinary Incontinence in Residents of a Long-Term Care FacilityNervous System Diseases | Neurologic Manifestations | Muscular Diseases | Neuromuscular Manifestations | Muscle Hypertonia | Spasticity, Muscle | Muscle Spasticity | Musculoskeletal Disease | Signs and SymptomsUnited States
-
Research Center of Neurology, RussiaCompletedConsciousness DisordersRussian Federation
-
Karolinska InstitutetLund UniversityCompleted
-
St. Jude Children's Research HospitalCompletedAcute Lymphoblastic LeukemiaUnited States
-
Vanderbilt University Medical CenterIpsenCompletedNervous System Diseases | Neurologic Manifestations | Muscular Diseases | Neuromuscular Manifestations | Muscle Hypertonia | Spasticity, Muscle | Muscle Spasticity | Musculoskeletal Disease | Signs and SymptomsUnited States
-
University Hospital, BordeauxCompleted
-
Rennes University HospitalCompletedMultiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Primary ProgressiveFrance
-
Ankara City Hospital BilkentCompletedSupracondylar Humerus Fractures | Nerve ExaminationTurkey (Türkiye)
-
Vanderbilt University Medical CenterVanderbilt Institute for Clinical and Translational ResearchCompletedNervous System Diseases | Neurologic Manifestations | Movement Disorders | Neuromuscular Manifestations | Cervical Dystonia | Focal Dystonia | Signs and Symptoms | Spasmodic TorticollisUnited States