Clinical Trials Logo

Clinical Trial Summary

The " Behavioural Addiction and Genetics in Parkinson's Disease " study (BADGE-PD) is a national (France), multicenter, genetic association, case-control study to identify genetic factors associated with behavioural addiction (or Impulse Control Disorders, ICD) related to dopamine agonists treatment in Parkinson's disease (PD). Polymorphisms of candidate genes supposed to be involved in this adverse effect will be compared in 200 PD patients with ICD (n=200) and 200 matched PD patients without ICD (n=200).


Clinical Trial Description

Objective: To identify susceptibility genes to impulse control disorders in Parkinson's Disease.

Study design: Genetic association study.

Primary objective:

To identify the susceptibility genes in behavior addiction in Parkinson's Disease

Secondary endpoints:

- To compare the clinical, neurological and psychiatric features of parkinsonian patients with behavior addiction compared to the control population. In case of differences between these groups, interaction will be studied with genetic factors

- Identify a psychometric profile from the TCI-R scale corresponding to the "hyperdopaminergic" subjects with AC personality

Patient selection:

Cases: patients with Parkinson's disease (PD) and impulse control disorder (ICD) as defined by a score greater than or equal to 2 or 3 scores greater than or equal to 2 at the "Evaluation Comportementale de la Maladie de Parkinson" scale (ECMP, Ardouin et al. 2009) for hyperdopaminergic items.

Controls: PD patients without impulse control disorder (ICD) as defined by a score of 0 or 1 at each hyperdopaminergic items AND no more than 2 items with a score of 1. Controls must have been treated with at least 300 mg of Levodopa equivalent daily dose for more than 12 months. Controls will be matched for sex, age, and age at onset of PD.

Number of subjects: 200 cases and 200 controls.

Clinical assessment: motor score (UPDRS), neuropsychological assessment, diagnostic criteria for addiction and ICD (MINI), self-administered psychometric questionnaire (TCI-R), treatment history, ICD history.

Genetic analysis: A blood sample will be taken for extraction and storage of DNA (DNA bank and Pitie-Salpetriere cells). Candidate genes* and polymorphisms will be selected from the literature data (receptors, transporters and metabolizing enzymes monoamine) and the molecular signature induced by L-DOPA in the striatum of a mice model of PD.

Statistical analysis:

A two-step analysis will be performed. For the first step, a training set (36% of subjects) will be analyzed with a logistic regression model considering an additive genetic effect. For the second step, the top 27% of the more significant genetic markers will be analyzed by using the left over replication set (64% of patients). Finally, a pooled analysis will be performed.

Sample Size: 200 patients per group to study 50 candidate markers with a power of 83% for genotype effect of 2.0, an additive genetic model, each allele frequency of 0.5.

* candidate genes list:

20 genes from the literature : DRD1, ANKK1, DRD2, DRD3, DRD4, DAT1, MAOA, COMT, HTR2A, HTR1B, TPH1, TPH2, 5HTT, GRIN2B, DBH, SCL6A2, BDNF, OPMR1, OPRK1, PDYN 8 genes from the experimentation: FosB, Arc, Nptx2, Ccrn4l, Car12, C8b, Mocs1, Mef2c ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02319395
Study type Observational
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase N/A
Start date November 2011
Completion date March 2016

See also
  Status Clinical Trial Phase
Completed NCT05415774 - Combined Deep Brain Stimulation in Parkinson's Disease N/A
Recruiting NCT04691661 - Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease Phase 2
Active, not recruiting NCT05754086 - A Multidimensional Study on Articulation Deficits in Parkinsons Disease
Completed NCT04045925 - Feasibility Study of the Taïso Practice in Parkinson's Disease N/A
Recruiting NCT04194762 - PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation N/A
Completed NCT02705755 - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05830253 - Free-living Monitoring of Parkinson's Disease Using Smart Objects
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Recruiting NCT06139965 - Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
Completed NCT04580849 - Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease N/A
Completed NCT04477161 - Effect of Ketone Esters in Parkinson's Disease N/A
Completed NCT03980418 - Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam N/A
Completed NCT04942392 - Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic N/A
Terminated NCT03446833 - LFP Beta aDBS Feasibility Study N/A
Completed NCT03497884 - Individualized Precise Localization of rTMS on Primary Motor Area N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT04997642 - Parkinson's Disease and Movement Disorders Clinical Database
Completed NCT04117737 - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson N/A
Recruiting NCT03618901 - Rock Steady Boxing vs. Sensory Attention Focused Exercise N/A