Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

December 14, 2007 updated by: Novartis
This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with mild cognitive impairment (MCI).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

24

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Safety of 16 week's treatment with rivastigmine in patients with mild cognitive impairment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

August 23, 2005

First Submitted That Met QC Criteria

August 23, 2005

First Posted (Estimate)

August 25, 2005

Study Record Updates

Last Update Posted (Estimate)

December 17, 2007

Last Update Submitted That Met QC Criteria

December 14, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CENA713BDE05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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