Diagnostic Tools for Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Realization of Diagnostic Tools for the Early Analysis of Parkinson's Disease Through the Identification of Genetic Risk Profiles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02403765
• Other study ID #: SMN01
• Status: Completed
• Start date: May 2015
• Est. completion date: October 31, 2019

Study information

• Verified date: October 2019
• Source: Neuromed IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

1. Clinical evaluation of PD patients and relatives

2. High throughput analysis of genetic variants in genome exomes

3. Genotype-phenotype association testing

4. Identification of genetic risk variants for PD

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: October 31, 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Italy	IRCCS Neuromed	Pozzilli

Sponsors (1)

Lead Sponsor	Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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