Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-05-31

Brief Summary

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

Detailed Description

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Conditions

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Cognitive Symptoms

Keywords

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Mild cognitive impairment Alzheimer's disease Dementia Mild Cognitive Impairment (MCI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Rivastigmine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Novartis Pharmaceuticals Corporation

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

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CENA713BDE05

Identifier Type: -

Identifier Source: org_study_id