A Longitudinal Study in 1st Degree Relatives of Parkinson... | NCT01502384

Studies
A Longitudinal Study in 1st Degree Relatives of Parkinson's Disease (PD) Patients

NCT01502384

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Dec 30, 2011Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Parkinson's Disease

Interventions

neurological examination

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jun 2015Estimated

Completion Date

Not provided

First Submitted Date

Dec 28, 2011

First Submission Date that Met QC Criteria

Dec 29, 2011

First Posted Date

Dec 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2011

Last Update Posted Date

Dec 30, 2011Estimated

Name	Class
Beth Israel Medical Center	OTHER
Columbia University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healthy relatives		healthy 1st degree relatives of PD patients	Other: neurological examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
neurological examination	Other	motor and cognitive functions	healthy relatives

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy 1ST degree realtives of PD patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anat Mirelman, PhD	Contact	972-3-6974958		anatmi@tasmc.health.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tel Aviv Sourasky Medical Center		Tel Aviv			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12941575	Background	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.
12428721	Background	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.

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases