Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease

This Clinical Investigation is a multicenter comparative randomized, controlled, masked (patient and primary criteria evaluator), superiority trial, with 2 parallel groups (Intervention group: Algorithm-guided arm; Control group: standard of care arm). PD patients, treated by DA at inclusion, will be randomized (1:1 ratio) either to the standard of care (SoC) arm, or to the Algorithm-guided arm. They will be recruited at PD expert centers of the NSPARK/FCRIN network. The primary objective is to assess the efficacy of the ICD SHIELD app, a software with a computer-based algorithm assisting clinicians in the prescription of dopaminergic medications, as compared to the standard of care, on the primary endpoint After the inclusion (V0 at M0), four follow-up visits will be performed : V1 at M6, V2 at M12, V3 at M18 and V4 at M24 during outpatients clinics where participants are usually followed. At each follow up visit (M6 to M24), the neurologist will record medical and treatment history, perform neurological examination MDS-UPDRS sections III to IV and CGI-I scale, and will review the MDS-UPDRS sections I and II for potential reassessment/clarification. The PGI scale, PDQ39 questionnaire, MDS-UPDRS sections I and II, and the HAD scales will be filled by the patient. The MoCA scale, ASBPD and QUIP-RS will be performed by a neuropsychologist, or an investigator trained for each scale, according to scoring instructions and blind to treatment arm allocation. Then, the treatment will be adapted by the neurologist, according to the recommendation by the algorithm output or to the clinician sole recommendation depending on the arm in which the patient is randomized. An additional phone call will be made 3 months after the previous visit for a remote checkup to confirm that the prescription change (decreasing or stopping DA) has been properly followed by the patient, if the adjustment to stop completely or decrease DA to a dose equivalent of 40mg of Levodopa was applied. An optional blood sample will be drawn at baseline or at a follow-up visit and sent for DNA extraction and biobanking at the ICM, Pitié-Salpêtrière Hospital, Paris. The duration of recruitment will be 2 years. The duration of participation for each participant will be 2 years, the total duration of the study will be 4 years. The main analysis will be in Intention to treat and will involve a mixed generalized linear model (GLMM) with a logit link adjusted for minimization stratification factors (center, sex, age, Levodopa Equivalent Daily Dose (LEDD) at inclusion).