Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

Novartis

Status and phase: Terminated; Phase 3

Conditions: Cognitive Symptoms

Treatments: Drug: Rivastigmine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00134953

CENA713BDE05

Details and patient eligibility

About

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

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind