The objective of this project is to study the role of dopaminergic mechanisms in apathy, mood and HDD in patients with PD. What is the involvement of the dopaminergic neurotransmitter system in motivation and reward processes in PD and the clinical…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are the performance on neuropsychiatric and
neuropsychological tests for both groups, including assessments of cognitive
status, mood, apathy, and an observation of spontaneous self-reward behaviour.
These outcome measures will be rated on three different testing days, before
and after the administration of methylphenidate, pramipexole or placebo.
Secondary outcome
not applicable
Background summary
In Parkinson's disease (PD) degeneration of dopaminergic cells in the
mesocorticolimbic pathway is implied int he pathophysiology of several
non-motor symptoms related to motivation and reward, such as apathy,
depression, and hedonistic homeostatic dysregulation (HDD), a syndrome that is
characterized by obsessive behaviour, addiction, compusive seeking of dopamine
replacement therapy (DRT), and hypersexuality. Apathy is reproted in 16 to 42 %
of PD patients, while depression occurs in in 25 to 40 %. Both apathy and
depression have a serious negative impact on everyday functioning, cognitive
and motor performance and quality of life for both patient and partner or
caretaker. HDD, although less prevalent (around 4% of patients), can also be
severely disruptive. Insight in the pathophysiology of these syndromes may pave
the way for rational treatments and improved outcomes.
Study objective
The objective of this project is to study the role of dopaminergic mechanisms
in apathy, mood and HDD in patients with PD. What is the involvement of the
dopaminergic neurotransmitter system in motivation and reward processes in PD
and the clinical correlates of dysfunction of reward systems in an experimental
approach?
Study design
A randomized double-blind placebo-controlled, crossover design with three arms.
Intervention
All subjects receive a 10 mg methylphenidate challenge, a 500 µg pramipexole
challenge and a placebo condition.
Study burden and risks
The burden and risks associated with the present study are related to three
visits on three separate days. Each day will start with the administration of a
neuropsychiatric and neuropsychological investigation (2,5 hours), observation
of spontaneous behaviour (15 minutes), accordingly the methylphenidate,
pramipexole challenge or placebo, and after 1.5 hours the outcome measures are
repeated (1,5 hours). Methylphenidate is used in previous studies in patients
with PD without reporting only some mild adverse events and pramipexole is a
common prescribed medication in PD patients, so burden en risks are expected to
be minimal. Because the main objective is to study the role of dopaminergic
mechanisms in apathy, mood and HDD in patients with PD, the inclusion of PD
patients in the present study is necessary.
Dr.Tanslaan 12
6229 ET
NL
Dr.Tanslaan 12
6229 ET
NL
Listed location countries
Age
Inclusion criteria
-Idopathic Parkinson's disease
-Informed consent
Exclusion criteria
-Other concurrent neurological diseases than PD
-Concurrent psychiatric disease
-Use of psychopharmacological medication
-Abuse of alcohol and drugs
-Cognitive deterioration as operationalized by a score of <23 on the MMSE
-Use of levodopa preparations of dopamine agonists.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-004810-14-NL |
| CCMO | NL19462.068.07 |