Evolution of Hypodopaminergic Syndrome in Early Parkinson's Disease (IMPACT)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Apathy; Parkinson Disease

Treatments: Other: Starkstein scale of Apathy

Study type: Observational

Funder types: Other

Identifiers

NCT03141944

38RC16.184

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 33 to 72 years old

Volunteers: No Healthy Volunteers

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)

Trial design

90 participants in 2 patient groups

Apathetic patients

Description:

De novo Parkinson's Disease patients with Apathy which participated in a former study and are under dopaminergic treatment at inclusion. All patients will be evaluated with regard to apathy, depression, pain, behavior and personality. Primary outcome measure is the degree of Apathy by the "Starkstein scale of apathy"

Treatment:

Other: Starkstein scale of Apathy

Non-apathetic patients

Description:

De novo Parkinson's Disease patients without Apathy which participated in a former study and are under dopaminergic treatment at inclusion. All patients will be evaluated with regard to apathy, depression, pain, behavior and personality. Primary outcome measure is the degree of Apathy by the "Starkstein scale of apathy"

Treatment:

Other: Starkstein scale of Apathy