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OpenTrials
Completed

NCT Number: NCT00099242

Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

The goal of this research study is to evaluate 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 Dementia, Alzheimer Type 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

Primary location

Santiago, Chile

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of dementia of the Alzheimer's type
  • Males, and females who are surgically sterile or one year postmenopausal
  • A primary caregiver willing to accept responsibility for supervising the treatment

Exclusion criteria

  • Any condition (other than Alzheimer's) that could explain patient's dementia
  • An advanced, severe or unstable disease that may put the patient at special risk
  • Current diagnosis of active, uncontrolled seizure disorder or unstable cardiovascular disease

Treatment and study plan

Rivastigmine transdermal patch

Drug

Primary outcomes

  1. Change in cognition from baseline at week 24

  2. Global clinical impression of change from baseline at week 24

Secondary outcomes

  1. Change from baseline at week 24 in activities of daily living

  2. Change from baseline at week 24 in behavioral symptoms

  3. Change from baseline at week 24 in global cognitive testing

  4. Change from baseline at week 24 in executive function

  5. Change from baseline at week 24 in attention

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2003
Study completion
2006
First posted
Dec 10, 2004
Registry last updated
Oct 13, 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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