Protocol of study for the evaluation of the efficacy of rivastigmine on cognitive and behavioural disorders, following traumatic brain injury TBI in chronic patients. - ND

• Conditions: Patients with cognitive and behavioural disorders following severe TBI and other severe acquired brain injury Glasgow Coma Scale GCS lower or equal 8; MedDRA version: 9.1Level: LLTClassification code 10057668Term: Cognitive disorder

• Registration Number: EUCTR2006-004435-30-IT
• Lead Sponsor: FONDAZIONE SANTA LUCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-12
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age between 18 and 55 years. Pathological performances in at least one test of the neuropsycological battery. 12 months minimum from traumatic brain injury. 12 weeks minimum between the last neuropsychological evaluation before the present study and the first experimental evaluation, in order to avoid learning effects
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Severe upper limbs motor impairment which hampers the possibility of the neuropsychological evaluation Severe speech impairment which hampers the possibility of the neuropsychological evaluation Mini Mental State Examination MMSE lower than 14 Token Test score age and school corrected equal to 0 Previous traumatic brain injury Previous or in progress uncontrolled diabetes mellitus Previous or in progress chronic ostructive broncopneumopathology Delay in electric cardiac conduction Peptic ulcera in progress Positive family or personal anamnesis for glaucoma Positive personal anamnesis for alcoholism Positive personal anamnesis for drug use or abuse Uncontrolled epilepsy presence of crisis in the last 6 months Pregnancy Psychiatric pathology in Axis I of the DSM IV-R major psychiatric disorders Known cholinesterase inhibitors ipersensibility Actual assumption of anticholinergic, neuroleptics or benzodiazepine drugs Chronic post-traumatic amnesia PTA Galveston Orientation Amnesia Test lower or equal to 75 Patient inability to give his own informed consent. Pharmacologically uncontrolled severe arterious hypertention

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the rivastigmine tolerability in a population of young adult patients not suffering from a degenerative illness i. e. Alzheimer Disease, in which this drug is already utilized ;Secondary Objective: Attentional, mnesic and behavioural improvement;Primary end point(s): Effects of rivastigmine in terms of family, social and work re-entry on patient with traumatic brain injury