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 ]

Efficacy will be assessed at 4 months as the change from baseline of the number of falls and near falls over the past 2 weeks using fall postcards sent weekly and filled daily by the subject and caregiver. The number of falls and near-falls will be expressed both as the total number of occurrences over that period and as the number of occurrence adjusted to the distance and number of hours walked (assessed using continuous accelerometer recordings)


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