- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01792843
Cognitive Phenotypes in Parkinson's Disease (CogPhenoPark)
Cognitive Phenotypes in Parkinson's Disease: Anatomical and Functional Correlates
- a data driven approach has identified different cognitive phenotypes in Parkinson's disease (PD)
- this heterogeneity possibly reflects the diversity of the neuronal damage caused by the disease
- we hypothesize that the different clinical presentations are associated to specific anatomical and functional correlates
Study Overview
Detailed Description
Cognitive impairments are frequent in PD, even in non-demented patients. However, there is a substantial heterogeneity in the clinical presentation of cognitive deficits in PD 2 and also in their progression. This heterogeneity possibly reflects the diversity of the neuronal damage caused by the disease and recent studies suggest that these different clinical influence the risk of developing dementia.
Most studies on cognitive phenotypes in PD have used predefined categories, such as demented vs. non-demented, or PD-mild cognitive impairment vs. cognitively intact patients. However, such an approach may miss less obvious or unexpected presentations. To this end, in a first part of this study, we have used a data-driven approach (cluster analysis) to identify different cognitive phenotypes in PD. With such an approach where phenotypical profiles arise from the data without a priori assumptions, five cognitive presentations were identified: i°) cognitively intact patients (19.39%), ii°) patients with slight mental slowing and mild executive dysfunction (41.29%), iii°) patients with slightly impaired overall cognitive efficiency and deficits in all cognitive domains except recognition memory (12.93%), iv°) patients with severe mental slowing, impaired overall cognitive efficiency, and severe cognitive impairment in all domains, including memory (23.88%), and v°) patients with very severe impairment in all cognitive domains (2.51%). From these results, it could be hypothesized that cognitive deterioration in PD progresses along a continuum, with the exception of the fourth group that also exhibits memory deficits. This group may be characterized by a different underlying pathology, or comorbidity with Alzheimer's disease. The role of vascular factors has also to be considered.
The objectives of the current project are:
- to validate the identified cognitive profiles prospectively in a new population using confirmatory cluster analysis.
- to identify specific anatomical correlates for the identified cognitive profiles by magnetic resonance-imaging (MRI) scanning
- to identify specific functional correlates of the identified cognitive profiles by high-density EEG (hd-EEG)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Maastricht, Netherlands
- Maastricht University Medical Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Males or females;
- 18 to 80 years;
- Parkinson's disease, according to international criteria;
- Without neurological co-morbidity;
- Benefiting from health insurance;
- Having read and understood the information form and having signed the consent form.
Exclusion Criteria:
- Pregnant or breastfeeding women;
- Parkinsonian syndrome other than PD;
- Currently participating in an other clinical trial or study;
- Patient whose physical or mental condition is incompatible with the study assessments;
- Person under tutorship or curatorship;
- Subjects with claustrophobia
- Subjects carrying incompatible metallic devices such as pacemakers and certain mechanical valves
- PD patients treated by deep brain stimulation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Parkinson's disease
Patients with Parkinson's disease according to international criteria
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency (%) of the cognitive profile
Time Frame: 2 years
|
Frequency of the different observed cognitive profile, as coming from the cluster analysis
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2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Grey matter density (voxels)
Time Frame: 2 years
|
Grey matter density as measured by voxel-based morphometry
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2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EEG power (microvolts2)
Time Frame: 2 years
|
EEG power in the different frequency bands
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kathy Dujardin, PhD, University Hospital, Lille
Publications and helpful links
General Publications
- Carey G, Lopes R, Viard R, Betrouni N, Kuchcinski G, Devignes Q, Defebvre L, Leentjens AFG, Dujardin K. Anxiety in Parkinson's disease is associated with changes in the brain fear circuit. Parkinsonism Relat Disord. 2020 Nov;80:89-97. doi: 10.1016/j.parkreldis.2020.09.020. Epub 2020 Sep 19.
- Dujardin K, Moonen AJ, Behal H, Defebvre L, Duhamel A, Duits AA, Plomhause L, Tard C, Leentjens AF. Cognitive disorders in Parkinson's disease: Confirmation of a spectrum of severity. Parkinsonism Relat Disord. 2015 Nov;21(11):1299-305. doi: 10.1016/j.parkreldis.2015.08.032. Epub 2015 Aug 29.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012_26
- 2012-A01317-36. (Other Identifier: ID-RCB number, ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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