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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Rivastigmine

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

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

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Corporation Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

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