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

August 23, 2005
December 14, 2007
January 2003
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16 week's treatment with rivastigmine on alertness, memory, attention, cognitive flexibility, orientation and language in patients with mild cognitive impairment
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Complete list of historical versions of study NCT00134953 on ClinicalTrials.gov Archive Site
Safety of 16 week's treatment with rivastigmine in patients with mild cognitive impairment
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Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment
Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

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

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Cognitive Symptoms
Drug: Rivastigmine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
May 2004
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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.

Both
50 Years to 85 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT00134953
CENA713BDE05
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Novartis
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Study Director: Novartis Pharmaceuticals Corporation Novartis Pharmaceuticals
Novartis
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP