Efficacy of RIVAstigmine on Motor, Cognitive and Behavioural Impairment in Progressive Supranuclear Palsy

Exclusion Criteria

• •Non ambulatory patient.
• •History and clinical examination suggesting another parkinsonian syndrome (Parkinson's disease, Dementia with Lewy Bodies, Corticobasal Degeneration, Multisystem Atrophy, Vascular Parkinsonism, tumoral parkinsonism, anti-psychotic drug-induced parkinsonism)
• •Presence of other significant neurological or psychiatric disorders: Alzheimer's disease, epilepsy, history of stroke, psychotic disorder, severe bipolar or unipolar disorder
• •A fall or near fall rate \< 2/week in average (during a 2-week period between screening and baseline using fall postcards).
• •Insufficient fluency in local language to complete neuropsychological, global and gait/balance assessments
• •Score \< 20 on the mini-mental state examination at screening
• •Within 4 weeks of screening or during the course of the study concurrent treatment with any cholinesterase inhibitor medication (donepezil, galantamine, rivastigmine) or any cholinergic agent (agonist or antagonist) including memantine.
• •History of deep brain stimulation surgery.
• •Within 4 weeks of screening or during the course of the study concurrent treatment with beta blockers, any antipsychotic drugs or mood stabilisers.
• •Any malignancy within 5 years of screening or current significant - judged as such by the site investigator - hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disease.
• •Presence of an active gastro-duodenal ulcer, unstable asthma or chronic obstructive pulmonary disease.
• •History of or current urinary retention requiring either anticholinergic medication or urethral catheterisation.
• •The systolic blood pressure measurement is \> 190 or \< 85 mm Hg and/or the diastolic blood pressure measurement is \> 105 or \< 50 mm Hg at screening.
• •Clinically significant laboratory abnormalities at screening, including creatinine ≥ 2.5 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times the upper limit of the normal reference range.
• •The ECG is abnormal at screening and judged to be clinically significant by the site investigator. Particular attention will be given to any sign suggesting conduction disorders.
• •Treatment with any investigational drugs or device within 60 days of screening.
• •Ongoing pregnancy or lactation. Women with childbearing potential not using any form of efficacious contraception.
• •Any contraindication for rivastigmine as defined by the ANSM
• •Known hypersensitivity to rivastigmine or any cholinesterase inhibitor medication.