Evolution of Hypodopaminergic Syndrome in Early Parkinson's Disease

NCT03141944 | Completed DMC

• 1 other identifier: 38RC16.184
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Parkinson Disease; Apathy

Keywords

non motor symptoms

Outcome Measures

Primary Outcomes (1)

• Evolution of apathy in Parkinson's disease

  Evolution of apathy in Patients with Parkinson's disease under dopaminergic treatment. The degree of apathy is evaluated with the "Starkstein Scale of Apathy".

  1day

Secondary Outcomes (8)

• Evolution of hypodopaminergia in Parkinson's disease

  1 day

• Apparition of hyperdopaminergic symptoms in Parkinson's disease

  1 day

• Evolution of impulsivity in Parkinson's disease

  1 day

• Evolution of personality in Parkinson's disease

  1 day

• Evolution of pain in Parkinson's disease

  1 day

Study Arms (2)

Apathetic patients

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"

Other: Starkstein scale of Apathy

Non-apathetic patients

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"

Other: Starkstein scale of Apathy

Interventions

Starkstein scale of Apathy OTHER

The degree of apathy will be evaluated with the "Starkstein scale of Apathy"

Apathetic patients; Non-apathetic patients

Eligibility Criteria

• Age: 33 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (4)

University Hospital of Grenoble

Grenoble, 38043, France

Location

Hôpital Neurologique Pierre Wertheimer

Lyon, France

Location

Centre Expert Régional pour la maladie de Parkinson

Poitiers, France

Location

Hôpital de Hautepierre

Strasbourg, France

Location

MeSH Terms

Conditions

Parkinson Disease; Lethargy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna CASTRIOTO, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: May 5, 2017
• Study Start: February 23, 2017
• Primary Completion: March 11, 2020
• Study Completion: March 11, 2020
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)