Parkinson's DiseasePADDONCT01249768
Parkinson's Disease, Diagnostic Observations (PADDO)
An observational study of Parkinson's Disease and Atypical Parkinsonism, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Background: Parkinson's Disease and the Atypical Parkinsonian Disorder (like Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Lewy Body Dementia) are disease entities with partly common symptomatology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease, Atypical Parkinsonism
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2010to Jul 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a hypokinetic-rigid syndrome with a disease duration of maximum 36 months and in whom a definitive diagnosis has not been established yet.
Who may be able to join
- Hypokinetic rigid syndrome
- Disease duration of maximum 36 months
Who cannot join
- Probable diagnosis of PD without any red flags
- Probable diagnosis MSA
- Probable diagnosis PSP
- Diagnosis CBD
- Diagnosis DLB
- Probable diagnosis Vascular Parkinsonism
Show all 9Show fewer
- Other neurodegenerative disease than parkinsonism
- A prior history of brain surgery
- Instable comorbidity
Trial locations and contacts
1 site in 1 country.
B Bloem, Prof, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Medical Centre
Nijmegen
About this study
Official title: Observational Study Assessing the Diagnostic Contribution of 3-Tesla MRI, CSF Analysis and a Second Opinion in a Specialized Movement Disorder Centre, in Differentiating Between Parkinson's Disease and Atypical Parkinsonism
Background:
Parkinson's Disease and the Atypical Parkinsonian Disorder (like Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Lewy Body Dementia) are disease entities with partly common symptomatology. Especially very early in the course of disease, the differentiation between both disease entities can be challenging, even for specialists in the field of movement disorder. However, the establishment of a correct diagnosis is very important for adequate patientcounseling, treatment and the correct inclusion of patients in research trials. Ancillary diagnostic investigations are looked upon to aid in this diagnostic dilemma.
Read more
Objective:
To investigate the value of ancillary diagnostic investigations, more specific MRI, analysis of cerebrospinal fluids and a second opinion in a specialized movement disorder centre, to differentiate Parkinson's disease and the Atypical Parkisonisonian disorder.
- Conditions
- Parkinson's Disease, Atypical Parkinsonism
- Keywords
- Prospective study, diagnostic accuracy, CSF, MRI
- 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 |
|---|---|---|
| Cohort | The cohort will consist of 150 patients with a hypokinetic rigid syndrome and a disease duration of maximum 36 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of correct diagnosis for each of the specified ancillary investigations
Percentage of correct diagnosis for each of the specified ancillary investigations to differentiate between either PD or atypical parkinsonism
Measured: 36 months
Secondary outcomes (1)
Percentage of correct diagnosis for each of the specified ancillary investigations
Percentage of correct diagnosis for each of the specified ancillary investigations(MRI, CSF analysis, and second opinion) to differentiate between the specific diagnosis (PD, MSA, PSP, CBD, LBD, VaP)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marjolein Aerts, Radboud University Medical Center
- Investigators
- M Verbeek, PhD, MSc, Principal investigator, Radboud University Medical CenterB Bloem, Prof, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249768
- Sponsor's protocol ID
- PADDO
- Acronym
- PADDO
- Status last verified
- Mar 2016
- First submitted
- 26 Nov 2010
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
van Rumund A, Aerts MB, Esselink RAJ, Meijer FJA, Verbeek MM, Bloem BR. Parkinson's Disease Diagnostic Observations (PADDO): study rationale and design of a prospective cohort study for early differentiation of parkinsonism. BMC Neurol. 2018 May 16;18(1):69. doi: 10.1186/s12883-018-1072-x.
PubMed 29764386
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Assessing the Diagnostic Contribution of 3-Tesla MRI, CSF Analysis and a Second Opinion in a Specialized Movement Disorder Centre, in Differentiating Between Parkinson's Disease and Atypical Parkinsonism
- ClinicalTrials.gov ID
- NCT01249768
- Acronym / sponsor ID
- PADDO / PADDO
- Conditions
- Parkinson's Disease, Atypical Parkinsonism
- Keywords
- Prospective study, diagnostic accuracy, CSF, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 30 Nov 2010 (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.
Background:
Parkinson's Disease and the Atypical Parkinsonian Disorder (like Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Lewy Body Dementia) are disease entities with partly common symptomatology. Especially very early in the course of disease, the differentiation between both disease entities can be challenging, even for specialists in the field of movement disorder. However, the establishment of a correct diagnosis is very important for adequate patientcounseling, treatment and the correct inclusion of patients in research trials. Ancillary diagnostic investigations are looked upon to aid in this diagnostic dilemma.
Objective:
To investigate the value of ancillary diagnostic investigations, more specific MRI, analysis of cerebrospinal fluids and a second opinion in a specialized movement disorder centre, to differentiate Parkinson's disease and the Atypical Parkisonisonian disorder.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –The cohort will consist of 150 patients with a hypokinetic rigid syndrome and a disease duration of maximum 36 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a hypokinetic-rigid syndrome with a disease duration of maximum 36 months and in whom a definitive diagnosis has not been established yet.
Key inclusion criteria (2 listed)
- Hypokinetic rigid syndrome
- Disease duration of maximum 36 months
Key exclusion criteria (9 listed)
- Probable diagnosis of PD without any red flags
- Probable diagnosis MSA
- Probable diagnosis PSP
- Diagnosis CBD
- Diagnosis DLB
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
percentage of correct diagnosis for each of the specified ancillary investigations
Time frame: 36 months
Percentage of correct diagnosis for each of the specified ancillary investigations to differentiate between either PD or atypical parkinsonism
1 secondary outcome
Percentage of correct diagnosis for each of the specified ancillary investigations
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Derived from this study: PubMed 29764386van Rumund A, Aerts MB, Esselink RAJ, Meijer FJA, Verbeek MM, Bloem BR. Parkinson's Disease Diagnostic Observations (PADDO): study rationale and design of a prospective cohort study for early differentiation of parkinsonism. BMC Neurol. 2018 May 16;18(1):69. doi: 10.1186/s12883-018-1072-x.
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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.
B Bloem, Prof, MD contact
M Verbeek, PhD, MSc principal investigator
Radboud University Medical Center
B Bloem, Prof, MD principal investigator
Radboud University Medical Center
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's Disease and Atypical Parkinsonism, run by Radboud University Medical Center at 1 site in Netherlands.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 31 Mar 2016. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact B Bloem, Prof, MD (b.bloem@neuro.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of correct diagnosis for each of the specified ancillary investigations (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01249768, which also lists 1 linked publication.
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 31 Mar 2016.