Traumatic Brain Injury (TBI)
Conditions
Interventions
Trade Name: Aricept
Product Name: Aricept (clorhidrate of donepezilo)
Product Code: E2020
Pharmaceutical Form: Tablet
INN or Proposed INN: Donezepilo
Concentration unit: mg milligram(s)
Concentration
Sponsors
Institut Universitari de Neurorehabiltació Guttmann
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Mild or severe TBI patients with Glasgow Coma Scale = 8 Awareness of a deficit in memory Memory affection detected by their families (Cuestionario de Olvidos Cotidianos-COC) Patients with cognitive functions preserved, able to focus and keep attention, to understand orders and give verbal and motor responses depending on the task to do. Are the trial subjects under 18? 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Premorbid intellectual alteration Psychiatric disorders TBIs recurrent Stroke or additional neurological pathology Aphasia and/or anomia Sensory disorders (Visual or Auditory problems) Aricept contraindications Neuropsycologic affectation (Attention Span less than 5 points) Posttraumatic amnesia Patient in legal procedures (indemnity stage)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): ;Secondary Objective: This is a double blind placebo controlled clinical trial associated to a systemized neuropsycological intervention. The study seeks to compare the efficacy of Donepezilo versus placebo in the rehabilitation of memory on people who are receiving a systemized neuropsycological treatment. Other purpose is to compare the efficacy of Donezepilo in patients with a neuropsycological intervention versus those who are not receiving such intervention. ;Main Objective: The objective of this trial is to assess the efficacy of Donepezilo (Aricept®) in the Neuropsycological Rehabilitation on TBI patients. | — |
Countries
Spain
Outcome results
None listed