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Completed

NCT Number: NCT00428389

Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease

This study was designed to evaluate the safety and tolerability of switching from donepezil to an initial dose of 5cm^2 rivastigmine patch formulation in patients with probable Alzheimer's Disease (MMSE 10-24). The study included a 5-week, open-label, randomized period followed by a 20-week open-label extension period. Patients were randomized to either an immediate switch from donepezil to rivastigmine patch formulation or to a switch to rivastigmine patch formulation following a 7-day withdrawal period.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dedicated Clinical Research, Sun City, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be at least 50 years of age;
  • Have a diagnosis of probable Alzheimer's Disease;
  • Have an MMSE score of > or = 10 and < or = 24;
  • Must have a caregiver who is able to attend all study visits;
  • Have received continuous treatment with donepezil for at least 6 months prior to screening, and received a stable dose of 5 mg/day or 10 mg/day for at least the last 3 of these 6 months.

Exclusion criteria

  • Have an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk;
  • Have a history of malignancy of any organ system, treated or untreated, within the past 5 years;
  • Have a history within the past year or current diagnosis of cerebrovascular disease;
  • Have a current diagnosis of severe or unstable cardiovascular disease; Have a history of myocardial infarction (MI) in the last six months;
  • Severe or unstable respiratory conditions (e.g., severe asthma , severe pulmonary (lung) disease);
  • Digestive problems related to peptic ulcer;
  • Urinary obstruction or current severe urinary tract infection;
  • Abnormal thyroid function tests;
  • Low folate or Vitamin B12;
  • Have a disability that may prevent the patient from completing all study requirements;
  • Have a current diagnosis of an active skin lesion/disorder that would prevent adhesion of a patch;

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Rivastigmine 5 cm^2 transdermal patch

Drug

Rivastigmine 5 cm^2 patch size, loaded with 9 mg and providing 4.6 mg rivastigmine per 24 hours.

Rivastigmine 10 cm^2 transdermal patch

Drug

Rivastigmine 10 cm^2 patch size loaded with 18 mg and providing 9.5 mg rivastigmine per 24 hours.

Primary outcomes

  1. Number of Participants Who Discontinued From the Study Due to Any Reason During the Core Phase of the Study

    Time frame: Baseline through the end of the core phase of the study (Week 5)

    The primary objective of the study was to evaluate the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD). The primary variable to assess tolerability of switching was the number of participants who discontinued from the study due to any reason during the core phase.

Secondary outcomes

  1. Number of Participants Who Discontinued From the Study Due to Any Adverse Event (AE) During the Combined Core and Extension Phases of the Study

    Time frame: Baseline through the end of study (25 weeks)

    A secondary assessment of the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD) was the number of participants who discontinued from the study due to an AE during the combined core and extension phases of the study.

  2. Number of Participants Who Discontinued From Study Due to Any Reason During Extension Phase

    Time frame: From week 5 through the end of extension phase (25 weeks)

    A secondary assessment of the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD) was the number of participants who discontinued from the study due to any reason during extension phases of the study.

  3. Mean Change From Baseline in the Clinical Global Impression of Change (CGIC) Score at Week 5 and Week 25

    Time frame: Baseline, Week 5 (end of the core phase) and Week 25 (end of the extension phase)

    The CGIC is an assessment tool used by a skilled clinician to make a judgment of the severity or a change of a patient's condition. The clinician relies solely on information obtained from the patient at the Baseline visit as well as clinical information obtained throughout the study period. The clinician does not have access to any post-baseline cognitive testing data. The CGIC is rated on a seven-point scale, ranging from (1) "very much improved" to (4) "no change" to (7) "very much worse".

  4. Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 25 and at the End of Study

    Time frame: Baseline and Week 25 (end of the extension phase) and at the end of study

    The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.

  5. Mean Change From Baseline in Neuropsychiatric Inventory - 10 Item (NPI-10) Score at Week 25 and at the End of Study.

    Time frame: Baseline, Week 25 (end of the extension phase) and at End of Study

    The NPI-10 assesses a wide range of behavior problems encountered in dementia patients. The 10 behavioral domains comprising the NPI-10 are evaluated through an interview of the caregiver by a mental health professional. The scale includes both frequency and severity ratings of each domain as well as a composite domain score (frequency x severity). The sum of the composite scores for the 10 domains yields the NPI total score, which ranges from 0 to 120, the lower the score the less severe the symptoms. A negative change score from baseline indicates improvement.

  6. Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 25 and at the End of Study

    Time frame: Baseline, Week 25 (end of the extension phase) and at the end of Study

    The ADCS-ADL scale is composed of 23 items to assess the basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, making judgments and decisions. Responses for each item are obtained through a caregiver interview. The total score is the sum of all items and sub-questions. The range for the total ADCS-ADL score is 0 to 78; a higher score indicates a more self-sufficient individual. A positive change from baseline indicates improvement.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Prospective, 5-Week, Open-Label, Randomized, Multi-Center, Parallel-Group Study With a 20-Week, Open-Label Extension Evaluating the Tolerability and Safety of Switching From Donepezil to an Initial Dose of 5 cm2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 30, 2007
Registry last updated
Jun 11, 2014

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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