Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment - Full Text View

Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

This study has been terminated.
( The Principal Investigator left the clinic and there was no one who could take over this study. )

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00134953

Purpose

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

Condition	Intervention	Phase
Cognitive Symptoms	Drug: Rivastigmine	Phase III

ChemIDplus related topics:

Rivastigmine SDZ-ENA 713

U.S. FDA Resources

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

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

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	24
Study Start Date:	January 2003
Study Completion Date:	May 2004

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134953

Sponsors and Collaborators

Novartis

Investigators


Study Director:	Novartis Pharmaceuticals Corporation	Novartis Pharmaceuticals

More Information

Study ID Numbers:	CENA713BDE05
First Received:	August 23, 2005
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00134953
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Mild cognitive impairment

Alzheimer's disease

Dementia

Mild Cognitive Impairment (MCI)

Study placed in the following topic categories:

Signs and Symptoms

Rivastigmine

Alzheimer Disease

Neurologic Manifestations

Dementia

Neurobehavioral Manifestations

Additional relevant MeSH terms:

Cholinesterase Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Enzyme Inhibitors

Cholinergic Agents

Central Nervous System Agents

Protective Agents

Neuroprotective Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008