Clinical Trial: Efficacy of RIVAstigmine on Motor, Cognitive and Behavioural Impairment in Progressive Supranuclear Palsy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: RIVA-PSP: Efficacy of Rivastigmine on Motor, Cognitive and Behavioural Impairment in Progressive Supranuclear Palsy: A Randomised Double Blind Placebo-controlled Clinical
Brief Summary:
Progressive supranuclear palsy (PSP) is a rare neurodegenerative disease from the parkinsonian syndrome group. It represents 5 to 10% of all parkinsonian syndromes and affects 3,000 to 10,000 persons in France. PSP is characterised by a doparesistant parkinsonism with axial signs such as early gait instability and falls, oculomotor signs such as a vertical gaze palsy, dysphagia and dysarthria, and both cognitive and behavioural disturbances. The latter predominantly manifest as psycho-motor slowness, apathy and frontal executive deficits. Swallowing impairments and falls may lead to life-threatening situations and death occurs 6-9 years after disease onset.
Apart from L-dopa which may transiently and inconsistently improve motor symptoms no effective symptomatic, disease-modifying or neuroprotective therapy is presently available to reduce disability in any way. Therefore these patients often receive mostly non-medical care such as physiotherapy and speech therapy.
In addition to dopaminergic degeneration there is evidence of cholinergic deficits in PSP correlated with gait and balance impairments . This stands in contrast with the limited number of studies of cholinergic augmentation strategies in PSP.
Trials of cholinesterase inhibitors in PSP have produced rather conflicting results: donepezil improves cognition but deteriorates some motor functions whereas a case series of 5 PSP patients treated with rivastigmine found an improvement in several cognitive aspects and no deterioration of motor functions .On the other hand in Parkinson's disease there is convincing evidence of a positive effect of rivastigmine on cognition , apathy and falls Investigators' hypothesis is that rivastigmine (an acetyl- and butyryl-cholinesterase inhibitor) may reduce gait and postural impairm
Detailed Summary:
Sponsor: Assistance Publique Hopitaux De Marseille
Current Primary Outcome: Efficacy will be assessed at 4 months as the change from baseline of the number of falls and near falls over the past 2 week [ Time Frame: baseline, 2 weeks, 4 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline at 4 months measured by the global ans sub scores of the PSPRS scale (Progressive Supranuclear Palsy Rating Scale) [ Time Frame: Baseline and 4 months ]
- Change from baseline at 4 months measured by the Clinical Global Impression scale (patient and caregiver) [ Time Frame: Baseline and 4 months ]
- Apathy assessed using the Lille Apathy Rating Scale (LARS) both subject and caregiver versions [ Time Frame: Baseline and 4 months ]
- Assessment of the Quality of life of patient using the PSP-Quality of Life Scale (PSP-QoL) [ Time Frame: Baseline and 4 months ]
- Assessment of the Quality of life of patient using the EQ-5D [ Time Frame: Baseline and 4 months ]
- Assessment of the Quality of life of the caregiver using the PSP-Quality of Life Scale (PSP-QoL) [ Time Frame: Baseline and 4 months ]
- Assessment of the Quality of life of the caregiver using the EQ-5D [ Time Frame: Baseline and 4 months ]
- Caregiver burden assessed using the Caregiver Reaction Assessement (CRA) [ Time Frame: Baseline and 4 months ]
- Safety: recording of adverse events at each study visit and at the phone calls [ Time Frame: 4 months ]Vital signs, laboratory tests and ECGs will be performed at each study visit to monitor any biological or cardiac adverse event
Original Secondary Outcome: Same as current
Information By: Assistance Publique Hopitaux De Marseille
Dates:
Date Received: June 30, 2016
Date Started: May 2016
Date Completion: November 2019
Last Updated: August 29, 2016
Last Verified: August 2016