Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline

Last updated: September 17, 2012
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Memory Loss

Dementia

Mild Cognitive Impairment

Treatment

N/A

Clinical Study ID

NCT00506415
CENA713D2340
  • Ages 50-85
  • All Genders

Study Summary

The purpose of this study was to support the optimal use of rivastigmine patch in long-term treatment of Alzheimer's Disease in patients demonstrating functional and cognitive decline at the target maintenance dose of rivastigmine patch 10 cm^2.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female patients between 50 and 85 years of age with a diagnosis of probableAlzheimers Disease,

  • Baseline Mini-Mental State Examination (MMSE) score 10-24 inclusive,

  • A primary caregiver willing to accept responsibility for supervising treatment,assessing the patient's condition throughout the study, and for providing input intoefficacy assessments.

  • For double blind only: Meet the decline criteria of functional (as assessed by theinvestigator) and cognitive (assessed by a 1 point reduction in Mini-Mental StateExamination) score between visits or a 3 point reduction from baseline) decline atweeks 23, 36 or 48.

Exclusion

Exclusion Criteria:

  • Presence of an advanced, severe, progressive, or unstable disease of any type thatcould interfere with efficacy and safety assessments or put the patient at particularrisk,

  • Any medical or neurological condition other than Alzheimers Disease that could explainthe patient's dementia,

  • A diagnosis of probable or possible vascular dementia,

  • A current diagnosis of unsuccessfully-treated depression, or any other mental disorderthat may interfere with the evaluation of the patient's response to study medication,

  • A history or current diagnosis of cerebrovascular disease (e.g. stroke),

  • A current diagnosis of severe or unstable cardiovascular disease (e.g. unstablecoronary artery disease). Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Total Participants: 1584
Study Start date:
June 01, 2007
Estimated Completion Date:
May 31, 2011

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