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

Completed · Phase 3 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT00506415

Run by

Novartis Pharmaceuticals

People needed

1584

Starts

2007-06-01

Expected to finish

2011-05-01

Last updated by the study team

2012-09-19

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients between 50 and 85 years of age with a diagnosis of probable Alzheimers 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 into efficacy assessments.
• For double blind only: Meet the decline criteria of functional (as assessed by the investigator) and cognitive (assessed by a 1 point reduction in Mini-Mental State Examination) score between visits or a 3 point reduction from baseline) decline at weeks 23, 36 or 48.

You may not qualify if…

• Presence of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments or put the patient at particular risk,
• Any medical or neurological condition other than Alzheimers Disease that could explain the patient's dementia,
• A diagnosis of probable or possible vascular dementia,
• A current diagnosis of unsuccessfully-treated depression, or any other mental disorder that 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. unstable coronary artery disease).
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis investigative site — Gilbert, Arizona, United States
• Novartis investigative site — Phoenix, Arizona, United States
• Novartis investigative site — Sun City, Arizona, United States
• Novartis investigative site — Anaheim, California, United States
• Novartis investigative site — Carson, California, United States
• Novartis investigative site — Costa Mesa, California, United States
• Novartis investigative site — Fullerton, California, United States
• Novartis investigative site — La Habra, California, United States
• Novartis investigative site — La Jolla, California, United States
• Novartis investigative site — National City, California, United States
• Novartis investigative site — Redlands, California, United States
• Novartis investigative site — San Francisco, California, United States
• Novartis investigative site — Fort Collins, Colorado, United States
• Novartis investigative site — Longmont, Colorado, United States
• Novartis investigative site — Boca Raton, Florida, United States
• Novartis investigative site — Bradenton, Florida, United States
• Novartis investigative site — Deerfield Beach, Florida, United States
• Novartis investigative site — Delray Beach, Florida, United States
• Novartis investigative site — Fort Lauderdale, Florida, United States
• Novartis investigative site — Gainesville, Florida, United States
• Novartis investigative site — Miami Beach, Florida, United States
• Novartis investigative site — Pompano Beach, Florida, United States
• Novartis investigative site — Port Charlotte, Florida, United States
• Novartis investigative site — Sunrise, Florida, United States
• Novartis investigative site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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