Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

Cognitive Symptoms Clinical Trial

Official title:

Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00134953
• Other study ID #: CENA713BDE05
• Status: Terminated
• Phase: Phase 3
• First received: August 23, 2005
• Last updated: December 14, 2007
• Start date: January 2003
• Est. completion date: May 2004

Study information

• Verified date: December 2007
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: May 2004
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Symptoms
• Mild Cognitive Impairment
• Neurobehavioral Manifestations

Intervention

Drug:
• Rivastigmine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	16 week's treatment with rivastigmine on alertness, memory, attention, cognitive flexibility, orientation and language in patients with mild cognitive impairment
Secondary	Safety of 16 week's treatment with rivastigmine in patients with mild cognitive impairment