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Cognitive Phenotypes in Parkinson's Disease (CogPhenoPark)

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ClinicalTrials.gov Identifier: NCT01792843
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
  • 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

Condition or disease Intervention/treatment
Parkinson Disease Behavioral: data

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:

  1. to validate the identified cognitive profiles prospectively in a new population using confirmatory cluster analysis.
  2. to identify specific anatomical correlates for the identified cognitive profiles by magnetic resonance-imaging (MRI) scanning
  3. to identify specific functional correlates of the identified cognitive profiles by high-density EEG (hd-EEG)

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Study Type : Observational
Actual Enrollment : 158 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cognitive Phenotypes in Parkinson's Disease: Anatomical and Functional Correlates
Study Start Date : January 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Parkinson's disease
Patients with Parkinson's disease according to international criteria
Behavioral: data
  • comparisons of clinical characteristics
  • comparisons of cognitive profiles
  • comparisons of grey matter density patterns
  • comparisons of EEG rhythms features




Primary Outcome Measures :
  1. Frequency (%) of the cognitive profile [ Time Frame: 2 years ]
    Frequency of the different observed cognitive profile, as coming from the cluster analysis


Secondary Outcome Measures :
  1. Grey matter density (voxels) [ Time Frame: 2 years ]
    Grey matter density as measured by voxel-based morphometry


Other Outcome Measures:
  1. EEG power (microvolts2) [ Time Frame: 2 years ]
    EEG power in the different frequency bands



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Parkinson's disease, according to international criteria, irrespective of their disease stage or their current antiparkinsonian medication
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792843


Locations
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Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Kathy Dujardin, PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01792843     History of Changes
Other Study ID Numbers: 2012_26
2012-A01317-36. ( Other Identifier: ID-RCB number, ANSM )
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases