Safety, Tolerability and Effects of Mannitol in Parkinson's Disease

Exclusion Criteria

• •1. Patients with motor deficits that require administration of symptomatic therapy more than 4 times per day at the day of visit 1.
• •2. Patients on advanced therapy for Parkinson's disease (sub-cutaneous apomorphine, deep brain stimulation or intra-jejunal levodopa infusion).
• •3. Patients with dementia reflected by a Mini-mental state examination (MoCA) ≥ 24.
• •4. Patient with legal guardian.
• •5. History of psychosis or use of dopamine receptor blocking agent on the year proceeding at the visit 1. Quetiapine at dose lower or equal 50 mg per day prescribed for indication other than psychosis is allowed.
• •6. Suspected Parkinsonian syndrome other than Parkinson's disease.
• •7. Use of medical marihuana on the month proceeding visit 1.
• •8. Pregnant or lactating women, or fertile woman who does not use contraceptive. Woman of child-bearing potential must have a negative urine Human chorionic gonadotropin (hCG) and will be monitored by repeated urine tests.
• •9. Patient with significantly impaired renal functions (urea or creatinine values 20% above the upper norm limit).
• •10. Diabetes mellitus.
• •11. Clinical evidence for congestive heart failure.
• •12. Patient with symptomatic orthostatic hypotension.
• •13. Based on investigator's opinion, any medical condition that may progress due to consumption of oral mannitol or glucose.