Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment
Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cognitive Symptoms
Intervention: Rivastigmine (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis Pharmaceuticals Corporation, Study Director, Affiliation: Novartis Pharmaceuticals
Summary
This study is designed to investigate the efficacy and safety of rivastigmine compared with
placebo in patients with mild cognitive impairment (MCI).
Clinical Details
Official title: Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: 16 week's treatment with rivastigmine on alertness, memory, attention, cognitive flexibility, orientation and language in patients with mild cognitive impairment
Secondary outcome: Safety of 16 week's treatment with rivastigmine in patients with mild cognitive impairment
Eligibility
Minimum age: 50 Years.
Maximum age: 85 Years.
Gender(s): 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.
Locations and Contacts
Additional Information
Starting date: January 2003
Last updated: December 14, 2007
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