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Completed

NCT Number: NCT01529619

Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease Switched From Cholinesterase Inhibitors

This is a multicenter study to evaluate the efficacy, safety and tolerability of Rivastigmine patch in patients with mild to moderate Alzheimer's disease switched from Cholinesterase Inhibitors.

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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 4

Primary location

Novartis Investigative Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria
  • A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
  • An MMSE score of > or = 10 and < or = 23
  • Continuous treatment with donepezil ≤ 5 mg/day or galantamine ≤ 24 mg/day for 4 weeks prior to baseline visit
  • Patients having difficulties being treated orally with ChE inhibitors (donepezil or galantamine) as judged by the investigator. Difficulties are defined as:
  • Inadequate compliance with the ChE inhibitors at screening and baseline
  • Presence of caregiver's burden for administering drugs orally at screening and baseline
  • Inadequate treatment (efficacious dose cannot be reached or inadequate compliance) with the ChE inhibitors because of adverse events at screening and baseline
  • Patients with swallowing difficulties at screening and baseline

Exclusion criteria

  • A current DSM-IV diagnosis of major depression
  • Taken rivastigmine in the past
  • A score of > 5 on the Modified Hachinski Ischemic Scale (MHIS)

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Rivastigmine transdermal patch

Drug

Primary outcomes

  1. Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J cog)

    Time frame: Baseline and Week 24

    The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline.

Secondary outcomes

  1. Adverse Events, Serious Adverse Events, Adverse event leading to discontinuation of study drug

    Time frame: Week 24

    Adverse Events: An adverse event is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug.

  2. Change From Baseline in Disability Assessment for Dementia (DAD)

    Time frame: Baseline and Week 24

    The Disability Assessment for Dementia (DAD) was used to assess levels of difficulty in activities of daily living (ADL). The DAD is administered through an interview with the caregiver. A total score is obtained by adding the rating for each question and converting this to a total score out of 100 (%). Higher scores represent less disability in ADL while lower scores indicate more dysfunction. A positive change score indicates an improvement from baseline.

  3. Change From Baseline in Mini-Mental State Examination (MMSE)

    Time frame: Baseline and Week 24

    The MMSE is a 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 from baseline.

  4. Change From Baseline in Japanese version of the Clinical global impression of change (J-CGIC)

    Time frame: Week 4, 8, 12, 16, 20, 24

    The J-CGIC is simple 7 grade investigator's impression scale (1. Markedly improved, 2. Improved, 3. Slightly improved, 4. No change, 5. Slightly aggravated, 6. Aggravated, 7. Markedly aggravated).

  5. Change From Baseline in Modified Crichton Scale

    Time frame: Baseline and Week 4, 8, 12, 16, 20, 24

    Modified Crichton Scale that assess basic activation of daily living, communication functions, and quality of life The following 7 items will be evaluated by caregiver. Total score is in the 0 to 56 range. Higher score means more severe impairment.

    Orientation, Conversation, Cooperation with family and caregiver, Restlessness, Dressing and clothes, Job and social activities/roles, Leisure activities

  6. Formulation usability questionnaire

    Time frame: Week 24

    The Formulation usability preference questionnaire had been used to compare the previous oral AD drugs versus the patch The caregiver selects one of the following answers (1. Very easy to use, 2. Easy to use, 3. No change, 4. Not easy to use, 5. Not easy to use at all, 6. Unknown). The reason for the answer should be recorded as possible.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

A 24-week, Open-label, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease (MMSE 10-23) Switched From Cholinesterase Inhibitors (Donepezil, Galantamine)

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 9, 2012
Registry last updated
Nov 18, 2016

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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