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OpenTrials
Completed

NCT Number: NCT00219232

An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

The goal of this research study is to evaluate, in the open-label extension phase, the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who fulfilled the inclusion and exclusion criteria as listed in the study CENA713D2320 and have completed the double-blind treatment phase on study medication without significant protocol violations.

Treatment and study plan

Rivastigmine transdermal patch

Drug

Primary outcomes

  1. Safety and tolerability as measured by adverse events, vital signs and skin irritation for up to 28 weeks treatment

Secondary outcomes

  1. Change in cognition from baseline (week 24 of the double blind phase) at week 52

  2. Clinical global impression of change from baseline at week 52

  3. Change in activities of daily living from baseline at week 52

  4. Change in behavioral symptoms from baseline at week 52

  5. Change in executive function from baseline at week 52

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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