Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment
This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with mild cognitive impairment (MCI)...
Brief Summary
Official Title: “Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment”
This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with mild cognitive impairment (MCI).
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Rivastigmine
Outcome Measures for this Clinical Trial
Primary Measures
- 16 week's treatment with rivastigmine on alertness, memory, attention, cognitive flexibility, orientation and language in patients with mild cognitive impairment
Secondary Measures
- Safety of 16 week's treatment with rivastigmine in patients with mild cognitive impairment
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 50 Years
Maximum Age for this Clinical Trial: 85 Years
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Corporation Study Director Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00134953
Study ID Number: CENA713BDE05
ClinicalTrials.gov Identifier: NCT00134953
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00134953
