Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00134953

Enrollment

Registered

2005-08-25

Start date

2003-01-31

Completion date

2004-05-31

Last updated

2007-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Symptoms

Keywords

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

Brief summary

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

Interventions

DRUGRivastigmine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
16 week's treatment with rivastigmine on alertness, memory, attention, cognitive flexibility, orientation and language in patients with mild cognitive impairment	—

Secondary

Measure	Time frame
Safety of 16 week's treatment with rivastigmine in patients with mild cognitive impairment	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026