Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment
Phase 3
Terminated
- Conditions
- Cognitive Symptoms
- Registration Number
- NCT00134953
- Lead Sponsor
- Novartis
- Brief Summary
This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with mild cognitive impairment (MCI).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 16 week's treatment with rivastigmine on alertness, memory, attention, cognitive flexibility, orientation and language in patients with mild cognitive impairment
- Secondary Outcome Measures
Name Time Method Safety of 16 week's treatment with rivastigmine in patients with mild cognitive impairment