Page 322 - Drug Class Review

Page 191 of 205
Drug Effectiveness Review Project
Evaluate the efficacy and safety of the centrally acting ChE inhibitor RIV tartrate for patients with mild

placebo N/A 26 weeks 235

Authors: Kumar et al. 91 (Subgroup analysis of Corey-Bloom et al.)

rivastigmine 6-12 mg/d 26 weeks 231 Age between 45 and 89 years; non-childbearing potential for females; criteria for AD according to DSM- IV; probable AD according to NINCDS/ADRDA criteria; mild-to-moderate impairment based on MMSE score between 10 and 26; head CT or MRI consistent with AD within 12 months of inclusion; responsible caregiver provided written consent [Note: see Corey-Bloom et al., 1998] Severe and unstable medical illnesses; use of anticholinergics AChE precursor health food supplements, memory enhancers, insulin, and psychotic drug

Drugs to moderately severe AD with or without concurrent VRF Setting: Multi-center (22) rivastigmine 1-4 mg/d 26 weeks 233 MHIS ≥ 5 were excluded from this analysis description in Corey-Bloom et al., 1998]

Alzheimer Year: 2000 Country: US Novartis Study design: RCT Sample size: 699

Final Report Update 1 Subgroups STUDY: FUNDING: RESEARCH OBJECTIVE: DESIGN: INTERVENTION: Dose: Duration: Sample size: INCLUSION: EXCLUSION: OTHER MEDICATIONS/ INTERVENTIONS ALLOWED: Alzheimer's Drugs