Author/Year/ Country/Study design/PEDro
Score |
Methods |
Outcome |
Silver et al. (2006)
USA
RCT
PEDro=9
N=123 |
Population: TBI. Rivastigmine (n=80): Mean Age=37 yr; Gender: Male=53, Female=27. Placebo (n=77): Mean Age=37.1 yr; Gender: Male=53, Female=24.
Intervention: Participants were randomized to receive either rivastigmine (3-6 mg/d) or placebo. At the end of the first 4 wk, rivastigmine doses were increased to 3.0 mg, 2x/d. If necessary doses were decreased to 1.5 mg or 4.5 mg 2x/d.
Outcome Measure: Trails A and B, Hopkins verbal learning test (HVLT), Cambridge Neuropsychological Test Automated Batter Rapid Visual Information Processing (CANTAB RVIP A). |
- Results of the CANTAB RVIP A’ and HVLT found no significant differences between the placebo group and the treatment group.
- Rivastigmine was found to be well tolerated and safe.
|
Silver et al. (2009)
USA
Pre-Post
N=127 |
Population: TBI. Ex-Rivastigmine (n=65): Mean Age=36.9 yr; Gender: Male=43, Female=22; Time Post Injury=73.5 mo.
Ex-placebo (n=62): Mean Age=38 yr; Gender: Male=42, Female=20; Time Post Injury=100.1 mo.
Intervention: Participants were randomized to receive rivastigmine injections (1.5 mg 2x/d to a max of 12 mg/d) or placebo injection.
Outcome Measure: Trails A and B, Hopkins verbal learning test (HVLT),Cambridge Neuropsychological Test Automated Batter Rapid Visual Information Processing (CANTAB RVIP A). |
- The mean final dose of rivastigmine was 7.9 mg/day.
- 40% of patients were responders on CANTAB RVIP A’ or HVLT score at week 38.
- At the end of the study period all (n=98) were seen to improve of the CANTAB RVIP A’ (p<0.001), the HVLT (P<0.001), and the Trails A and B (p<0.001).
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