Parkinson DiseaseNCT02403765
Diagnostic Tools for Parkinson's Disease
An observational study of Parkinson Disease, run by Neuromed IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- May 2015to 31 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Realization of Diagnostic Tools for the Early Analysis of Parkinson's Disease Through the Identification of Genetic Risk Profiles
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
- Clinical evaluation of PD patients and relatives
- High throughput analysis of genetic variants in genome exomes
- Genotype-phenotype association testing
- Identification of genetic risk variants for PD
- Conditions
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Family cases | Family-based Parkinson patients carrying genetic variants associated with the disease | |
| Family controls | Family-based Control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2018
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Simeone, Neuromed IRCCS
- Investigators
- Antonio Simeone, Principal investigator, IRCCS Neuromed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403765
- Sponsor's protocol ID
- SMN01
- Status last verified
- Oct 2019
- First submitted
- 26 Mar 2015
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Realization of Diagnostic Tools for the Early Analysis of Parkinson's Disease Through the Identification of Genetic Risk Profiles
- ClinicalTrials.gov ID
- NCT02403765
- Acronym / sponsor ID
- SMN01
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Clinical evaluation of PD patients and relatives
- High throughput analysis of genetic variants in genome exomes
- Genotype-phenotype association testing
- Identification of genetic risk variants for PD
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family cases | – | –Family-based Parkinson patients carrying genetic variants associated with the disease |
| Family controls | – | –Family-based Control subjects |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of genetic variants associated with Parkinson's disease
Time frame: Two years
Analysis of exome sequencing data; annotation of genetic variants; selection of variants present in cases and absent in controls
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Simeone principal investigator
IRCCS Neuromed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Neuromed IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of genetic variants associated with Parkinson's disease (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.