NCT02403765

Brief Summary

The study aims to identify genetic variants associated to Parkinson's disease through the analysis of exome-sequencing data of familial cases and controls. The identified variants will be used to generate a diagnostic tool for the identification of genetic risk profiles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

3.4 years

First QC Date

March 26, 2015

Last Update Submit

October 31, 2019

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Identification of genetic variants associated with Parkinson's disease

    Analysis of exome sequencing data; annotation of genetic variants; selection of variants present in cases and absent in controls

    Two years

Study Arms (2)

Family cases

Family-based Parkinson patients carrying genetic variants associated with the disease

Family controls

Family-based Control subjects

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients will be selected from the Center for Parkinson's disease of the IRCCS Neuromed, according to specific inclusion criteria. Approximatey 500 subjects, 30 years of age or older, recruited with a family-based approach, will be included in the study.

You may qualify if:

  • Presence of at least two out the following cardinal signs: resting tremor, cogwheel rigidity, bradykinesia, asymmetrical onset of symptoms and symptomatic response to L-dopa (levodopa)

You may not qualify if:

  • Previous thalamotomy on the implanted sided, significant brain atrophy or structural damage seen on CT or MRI, marked cognitive dysfunction, active psychiatric symptoms, or concurrent neurological or other uncontrolled medical disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Neuromed

Pozzilli, 86077, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for DNA extraction

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Antonio Simeone

    IRCCS Neuromed

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head

Study Record Dates

First Submitted

March 26, 2015

First Posted

March 31, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2018

Study Completion

October 31, 2019

Last Updated

November 4, 2019

Record last verified: 2019-10

Locations

IT(1)