Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

• Status: Terminated
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with mild cognitive impairment (MCI).

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Rivastigmine

Criteria

Inclusion Criteria:

• Males or females who are one year post-menopausal or without childbearing potential

• Between the ages of 50 and 85 years old

• Mild cognitive impairment confirmed by Mini Mental State Examination (MMSE) score between 23 and 27

• Cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver, according to the investigator's judgement

Exclusion Criteria:

• A current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances or secondary dementia

• A current diagnosis of epilepsy or depression, or any other diagnosis that may interfere with the patient's response to study medication

• An advanced, severe or unstable disease of any type that may interfere with efficacy evaluations

Other protocol-defined exclusion criteria may apply.