Parkinson DiseaseCogPhenoParkNCT01792843
Cognitive Phenotypes in Parkinson's Disease
An observational study of Parkinson Disease, run by University Hospital, Lille at 1 site in Netherlands.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- data
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 158 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2013to Dec 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's disease, according to international criteria, irrespective of their disease stage or their current antiparkinsonian medication
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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)
- Conditions
- Parkinson Disease
- Being tested
- data
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dataBehavioural
- comparisons of clinical characteristics
- comparisons of cognitive profiles
- comparisons of grey matter density patterns
- comparisons of EEG rhythms features
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease | Patients with Parkinson's disease according to international criteria Receives: Behavioral: data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency (%) of the cognitive profile
Frequency of the different observed cognitive profile, as coming from the cluster analysis
Measured: 2 years
Secondary outcomes (1)
Grey matter density (voxels)
Grey matter density as measured by voxel-based morphometry
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathy Dujardin, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792843
- Sponsor's protocol ID
- 2012_26
- Other IDs
- 2012-A01317-36.
- Acronym
- CogPhenoPark
- Status last verified
- Feb 2017
- First submitted
- 13 Feb 2013
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26350121Carey 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.
PubMed 32979785
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Phenotypes in Parkinson's Disease: Anatomical and Functional Correlates
- ClinicalTrials.gov ID
- NCT01792843
- Acronym / sponsor ID
- CogPhenoPark / 2012_26
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Feb 2013 (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.
- 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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease | – | Behavioral: dataPatients with Parkinson's disease according to international criteria |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease, according to international criteria, irrespective of their disease stage or their current antiparkinsonian medication
Key inclusion criteria (6 listed)
- Males or females;
- 18 to 80 years;
- Parkinson's disease, according to international criteria;
- Without neurological co-morbidity;
- Benefiting from health insurance;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data* comparisons of clinical characteristics * comparisons of cognitive profiles * comparisons of grey matter density patterns * comparisons of EEG rhythms features | Behavioural | Parkinson's disease |
Primary outcome
Frequency (%) of the cognitive profile
Time frame: 2 years
Frequency of the different observed cognitive profile, as coming from the cluster analysis
1 secondary outcome
Grey matter density (voxels)
Time frame: 2 years
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 14 May 2026.
- Results publication: PubMed 26350121Dujardin 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.
- Derived from this study: PubMed 32979785Carey 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.
- Individual participant dataSharing planned: No
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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.
Kathy Dujardin, PhD principal investigator
University Hospital, Lille
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 University Hospital, Lille 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 6 inclusion and 8 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 14 May 2026. 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?
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?
Frequency (%) of the cognitive profile (time frame: 2 years). 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 NCT01792843, which also lists 2 linked publications.
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 14 May 2026.