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:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00134953
First received: August 23, 2005
Last updated: December 14, 2007
Last verified: December 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

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
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, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00134953     History of Changes
Other Study ID Numbers: CENA713BDE05
Study First Received: August 23, 2005
Last Updated: December 14, 2007
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)

Additional relevant MeSH terms:
Cognition Disorders
Neurobehavioral Manifestations
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014