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Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cognitive Symptoms

Intervention: Rivastigmine (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals Corporation, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

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

Clinical Details

Official title: Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: 16 week's treatment with rivastigmine on alertness, memory, attention, cognitive flexibility, orientation and language in patients with mild cognitive impairment

Secondary outcome: Safety of 16 week's treatment with rivastigmine in patients with mild cognitive impairment

Eligibility

Minimum age: 50 Years. Maximum age: 85 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: January 2003
Last updated: December 14, 2007

Page last updated: August 20, 2015

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