NCT00134953

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_3

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2005

Completed
Last Updated

December 17, 2007

Status Verified

December 1, 2007

First QC Date

August 23, 2005

Last Update Submit

December 14, 2007

Conditions

Cognitive Symptoms

Keywords

Mild cognitive impairmentAlzheimer's diseaseDementiaMild Cognitive Impairment (MCI)

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

RivastigmineDRUG

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neurobehavioral ManifestationsCognitive DysfunctionAlzheimer DiseaseDementia

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

PhenylcarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Novartis Pharmaceuticals Corporation

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 25, 2005

Study Start

January 1, 2003

Study Completion

May 1, 2004

Last Updated

December 17, 2007

Record last verified: 2007-12