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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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00134953
First Posted: August 25, 2005
Last Update Posted: December 17, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134953


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Corporation Novartis Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00134953     History of Changes
Other Study ID Numbers: CENA713BDE05
First Submitted: August 23, 2005
First Posted: August 25, 2005
Last Update Posted: December 17, 2007
Last Verified: December 2007

Keywords provided by Novartis:
Mild cognitive impairment
Alzheimer's disease
Dementia
Mild Cognitive Impairment (MCI)

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Neurobehavioral Manifestations
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents