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CompletedNCT02403765Updated Nov 4, 2019

Diagnostic Tools for Parkinson's Disease

An observational study in Parkinson Disease, sponsored by Neuromed IRCCS. Completed at 1 site in Italy. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-04.

Sponsored by Neuromed IRCCS · Observational

Study type
Observational
Model
Family-based
Time perspective
Cross-sectional
Enrollment
500
Ages
30 Years and older
Sex
All
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Study 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.

Read the detailed 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
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Conditions studied

  • Parkinson Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 500 is above the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

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Lead sponsor

Neuromed IRCCS is the lead sponsor of 76 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability 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.

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

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.
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Study design

Observational model
Family-based
Time perspective
Cross-sectional
Enrollment
500 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Family cases

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

  • Family controls

    Family-based Control subjects

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What researchers measure

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

    Time frame: Two years

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Study locations

1 site
  • IRCCS Neuromed
    Pozzilli, 86077, Italy
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02403765
Lead sponsor
Neuromed IRCCS
Responsible party
Antonio Simeone (Head, Neuromed IRCCS) — Principal investigator
First posted
Mar 31, 2015
Start date
May 2015
Primary completion
Oct 2018
Completion
Oct 31, 2019
Last update
Nov 4, 2019

Study contacts

Antonio Simeone
principal investigator · IRCCS Neuromed

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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