Apathy in Parkinson DiseaseNCT01020682
Apathy in Parkinson Disease: Clinical, Physiopathological and Pharmacological Study
An observational study of Apathy in Parkinson Disease, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Apathy has been reported to occur after subthalamic nucleus stimulation (STN-DBS), a treatment of motor complications in advanced Parkinson's disease (PD). It is not known whether postoperative apathy is related to dopamine withdrawal or a side effect of STN DBS. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Apathy in Parkinson Disease
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2005to Jun 2011
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's disease
Who may be able to join
- Parkinson disease
Who cannot join
- Mattis scale < 130
- Beck scale > 20
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital neurologique
Lyon, 69000
Broussolle, MD
About this study
Apathy has been reported to occur after subthalamic nucleus stimulation (STN-DBS), a treatment of motor complications in advanced Parkinson's disease (PD). It is not known whether postoperative apathy is related to dopamine withdrawal or a side effect of STN DBS. The researchers investigated potential predictors of apathy, and the effect of dopamine agonist treatment.
- Conditions
- Apathy in Parkinson Disease
- Keywords
- apathy, parkinson, agonist dopaminergic
- Medical subject headings
- Lethargy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startJan 2005
- Primary completionFeb 2006
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apathy in Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020682
- Sponsor's protocol ID
- APATHIE
- Status last verified
- Nov 2009
- First submitted
- 24 Nov 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apathy in Parkinson Disease: Clinical, Physiopathological and Pharmacological Study
- ClinicalTrials.gov ID
- NCT01020682
- Acronym / sponsor ID
- APATHIE
- Conditions
- Apathy in Parkinson Disease
- Keywords
- apathy, parkinson, agonist dopaminergic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Jan 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Jun 2011 (estimated)
- First posted
- 25 Nov 2009 (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.
Apathy has been reported to occur after subthalamic nucleus stimulation (STN-DBS), a treatment of motor complications in advanced Parkinson's disease (PD). It is not known whether postoperative apathy is related to dopamine withdrawal or a side effect of STN DBS. The researchers investigated potential predictors of apathy, and the effect of dopamine agonist treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease
Key inclusion criteria (1 listed)
- Parkinson disease
Key exclusion criteria (2 listed)
- Mattis scale < 130
- Beck scale > 20
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2009.
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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.
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 Apathy in Parkinson Disease, run by University Hospital, Grenoble at 1 site in France.
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 2 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 25 Nov 2009. 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 France. 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 Krack Paul, MD (0476765791, paul.krack@ujf-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 25 Nov 2009.