← Trials/Trial dossier/NCT00134953

TerminatedPhase 3

Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

Lead sponsor

Novartis

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

Study population

MCI / preclinical Alzheimer’s

Key I/E criteria

•MMSE 23-27•Study partner/caregiver required

Primary endpoint

•16 week's treatment with rivastigmine on alertness, memory, attention

Identifiers

Registered as

Org study IDCENA713BDE05

NCT IDNCT00134953

Timeline

Milestones

Study start2003-01 (month precision)

Study completion2004-05actual (month precision)

Study first posted2005-08-25estimated

Last update posted2007-12-17estimated

Assets

Drug assets

Rivastigmine

Study populations

Who this study enrolls

MCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Memory

Safety / tolerability / PK

Memory

1 endpoint

Primary/protocol endpoint

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

descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Safety of 16 week's treatment with rivastigmine in patients with mild cognitive impairment

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.