Clinical trial NCT03141944: Evolution of Hypodopaminergic Syndrome in Early Parkinson's Disease
Official title: Improvement of Hypodopaminergic Syndrome With Dopaminergic Treatment in Early Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Apathy
Keywords: non motor symptoms
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 90
Sex: ALL
Minimum age (years): 33
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinon's disease who participated in "Non Motors Aspects in De Novo Parkinson's Disease (Honeymoon)" NCT02786667 between june 2012 and june 2016

Brief summary: The objective of this study is to describe the evolution of hypodopaminergic syndrome in patients with Parkinson's disease.

Detailed description: All patients to be included have been clinically described in the early phase of their disease, before instauration of dopaminergic treatment, in the context of a former study ("Non Motor Aspects in De Novo Parkinson's Disease (Honeymoon) NCT02786667") between june 2012 and june 2016.

3 to 5 years after this study, those patients who started dopaminergic treatment will be evaluated again.

The objective of this study, which takes place 3 to 5 year after the initial evaluation, is to measure the evolution of apathy and other symptoms of the hypodopaminergic syndrome.

Secondary objectives are the evolution of other parameters including pain, personality and behavior. All parameters measured have been determined of each patient in the Honeymoon study.

Eligibility criteria: Inclusion Criteria:

* patients who participated in "Non Motors Aspects in De Novo Parkinson's Disease (Honeymoon)" NCT02786667
* Patients under dopaminergic treatment, with stable dopaminergic treatment for at least 2 months
* Patients with medical insurance
* signed informed consent

Exclusion Criteria:

* diagnosis other than Parkinson's Disease
* dementia (Mattis \<130)
* patients protected by law (i.e. pregnant or parturient women)

Primary outcomes:
measure: Evolution of apathy in Parkinson's disease
timeFrame: 1day
Secondary outcomes:
measure: Evolution of hypodopaminergia in Parkinson's disease
timeFrame: 1 day
measure: Apparition of hyperdopaminergic symptoms in Parkinson's disease
timeFrame: 1 day
measure: Evolution of impulsivity in Parkinson's disease
timeFrame: 1 day
measure: Evolution of personality in Parkinson's disease
timeFrame: 1 day
measure: Evolution of pain in Parkinson's disease
timeFrame: 1 day
measure: Evolution of quality of life in Parkinson's disease
timeFrame: 1 day
measure: Evolution of somnolence in Parkinson's disease
timeFrame: 1 day
measure: Evolution of eating behavior in Parkinson's disease
timeFrame: 1 day
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
city: Lyon
country: France
facility: Hôpital Neurologique Pierre Wertheimer
city: Poitiers
country: France
facility: Centre Expert Régional pour la maladie de Parkinson
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
Study officials:
affiliation: University Hospital, Grenoble
name: Anna CASTRIOTO, MD
role: PRINCIPAL_INVESTIGATOR
References: