| Study |
Objective |
| B103 |
To assess the short term (3 months) symptomatic efficacy and tolerability of rivastigmine 4 and 6 mg/day compared with placebo in patients with AD |
| B104 |
Primary: to determine the maximum tolerated dose (MTD) of rivastigmine in patients with mild to moderate dementia of the Alzheimer type (DAT) |
| Secondary: to determine ‐ a) whether tolerability is different when the drug is administered twice daily (b.i.d.) or three times daily (t.i.d.) ‐ b) if nausea and vomiting, associated with cholinesterase inhibition, can be controlled with antiemetics thereby increasing the MTD, and ‐ c) to assess the efficacy of rivastigmine at its MTD in comparison with that of placebo in the treatment of DAT |
| B303/B305 |
Primary 1: to evaluate the efficacy of two non‐overlapping dose ranges of rivastigmine (1 to 4mg daily and 6 to 12 mg daily) versus placebo over a 26 week treatment period as assessed by two primary measures of outcome; change from baseline in ADAS‐Cog score and the CIBIC‐Plus score at week 26 |
| Primary 2: to evaluate the safety of the study medication as assessed by incidence of adverse events, clinical laboratory evaluations , vital signs, ECG recordings, and the results of physical examination made at baseline and throughout the study |
| Secondary: to assess dose‐efficacy and dose‐safety relationships for rivastigmine |
| B304 |
Primary: to evaluate the efficacy and safety of individual highest well‐tolerated doses (range 6 to 12 mg daily) of rivastigmine given b.i.d. or t.i.d. for 26 weeks compared with placebo in the therapy of patients with probable Alzheimer's disease |
| Secondary: to compare the twice daily and three times daily dosing regimens with respect to efficacy and safety to evaluate changes in activities of daily living (ADL) |
| B351 |
Primary: to evaluate the efficacy and safety of three fixed doses of rivastigmine (3, 6 and 9 mg/day) and placebo for 26 weeks of treatment |
| Secondary: to assess the dose‐efficacy and dose‐safety relationships for rivastigmine |
| Tertiary: to explore the pharmacokinetics of rivastigmine at doses of 3, 6 and 9 mg daily |
| B352 |
Primary: to evaluate the efficacy and safety of two non‐overlapping dose ranges of rivastigmine (1 to 4 mg daily and 6 to 12 mg daily) and placebo for 26 weeks of treatment |
| Secondary: to assess the dose‐efficacy and dose‐safety relationships of rivastigmine. To investigate the relationship between plasma concentrations of rivastigmine and efficacy and safety |
| Tertiary: to explore the pharmacokinetics of rivastigmine at doses of 1 to 4 and 6 to 12 mg daily |
| IDEAL |
To compare the efficacy,safety and tolerability of a novel rivastigmine transdermal patch with conventional rivastigmine capsules and placebo in patients with AD |
| Karaman 2005 |
To evaluate the efficacy of rivastigmine for a period of 12 months in patients with advanced moderate AD |
| Lopez‐Pousa 2005 |
To evaluate the safety and efficacy of rivastigmine in patients with more advanced AD |
| Mowla 2007 |
To assess the effect of serotonin augmentation on cognition and ADL of patients with AD |
| Ballard 2005 |
To determine whether rivastigmine was better than placebo for agitation and cognition |
| Tai 2000 |
To evaluate the safety and efficacy of Exelon compared with placebo in patients with probable Alzheimer's disease who had dementia ranging from mild to moderate degree |
| Nakamura 2011 |
To evaluate the efficacy, safety, and tolerability of the 5 cm2 (9 mg loading dose, 4.6 mg/24 h delivery rate) and 10 cm2 (18 mg loading dose, 9.5 mg/day delivery rate) rivastigmine patch in Japanese patients with AD |
