Dementia of the Alzheimer’s type   
  
The effectiveness of Rivastigmine Tartrate Capsules as a treatment for Alzheimer’s Disease is demonstrated by the results of 2 randomized, double-blind, placebo-controlled clinical investigations in patients with Alzheimer’s Disease [diagnosed by NINCDS-ADRDA and DSM-IV criteria, Mini-Mental State Examination (MMSE) ≥10 and ≤26, and the Global Deterioration Scale (GDS)]. The mean age of patients participating in Rivastigmine Tartrate Capsules trials was 73 years with a range of 41 to 95. Approximately 59% of patients were women and 41% were men. The racial distribution was Caucasian 87%, Black 4% and Other races 9%.  
  
Study Outcome Measures: In each study, the effectiveness of Rivastigmine Tartrate Capsules was evaluated using a dual outcome assessment strategy.  
  
The ability of Rivastigmine Tartrate Capsules to improve cognitive performance was assessed with the cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog), a multi item instrument that has been extensively validated in longitudinal cohorts of Alzheimer’s Disease patients. The ADAS-cog examines selected aspects of cognitive performance including elements of memory, orientation, attention, reasoning, language and praxis. The ADAS-cog scoring range is from 0 to 70, with higher scores indicating greater cognitive impairment. Elderly normal adults may score as low as 0 or 1, but it is not unusual for non-demented adults to score slightly higher.  
  
The patients recruited as participants in each study had mean scores on ADAS-cog of approximately 23 units, with a range from 1 to 61. Experience gained in longitudinal studies of ambulatory patients with mild to moderate Alzheimer’s Disease suggests that they gain 6 to 12 units a year on the ADAS-cog. Lesser degrees of change, however, are seen in patients with very mild or very advanced disease because the ADAS-cog is not uniformly sensitive to change over the course of the disease. The annualized rate of decline in the placebo patients participating in Rivastigmine Tartrate Capsule trials was approximately 3 to 8 units per year.  
  
The ability of Rivastigmine Tartrate Capsules to produce an overall clinical effect was assessed using a Clinician’s Interview Based Impression of Change (CIBIC) that required the use of caregiver information, the CIBIC-Plus. The CIBIC-Plus is not a single instrument and is not a standardized instrument like the ADAS-cog. Clinical trials for investigational drugs have used a variety of CIBIC formats, each different in terms of depth and structure. As such, results from a CIBIC-Plus reflect clinical experience from the trial or trials in which it was used and can not be compared directly with the results of CIBIC-Plus evaluations from other clinical trials. The CIBIC-Plus used in the Rivastigmine Tartrate Capsules trials was a structured instrument based on a comprehensive evaluation at baseline and subsequent time-points of three domains: patient cognition, behavior and functioning, including assessment of activities of daily living. It represents the assessment of a skilled clinician using validated scales based on his/her observation at interviews conducted separately with the patient and the caregiver familiar with the behavior of the patient over the interval rated. The CIBIC-Plus is scored as a 7 point categorical rating, ranging from a score of 1, indicating “markedly improved,” to a score of 4, indicating “no change” to a score of 7, indicating “marked worsening.” The CIBIC-Plus has not been systematically compared directly to assessments not using information from caregivers or other global methods.