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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01529619
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : November 18, 2016
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Rivastigmine transdermal patch Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Study Start Date : March 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: Rivastigmine 18 mg
During the 16-week titration period patients received daily rivastigmine 4.5mg patch for the first 4 weeks, rivastigmine 9mg patch for the next 4 weeks, rivastigmine 13.5mg patch for the next 4 weeks and then rivastigmine 18mg patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
Drug: Rivastigmine transdermal patch

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01529619

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Novartis Investigative Site
Nagoya-city, Aichi, Japan, 467-8602
Novartis Investigative Site
Fukuoka-city, Fukuoka, Japan, 814-0180
Novartis Investigative Site
Miyoshi-city, Hiroshima, Japan, 728-0013
Novartis Investigative Site
Ohtake, Hiroshima, Japan, 739-0696
Novartis Investigative Site
Kita-gun, Kagawa, Japan, 761-0793
Novartis Investigative Site
Kamakura-city, Kanagawa, Japan, 247-8533
Novartis Investigative Site
Kawasaki-city, Kanagawa, Japan, 216-8511
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 241-0811
Novartis Investigative Site
Koshi-city, Kumamoto, Japan, 861-1116
Novartis Investigative Site
Kyoto-city, Kyoto, Japan, 600-8558
Novartis Investigative Site
Kyoto, Japan, 606-0851
Sponsors and Collaborators
Novartis Pharmaceuticals
Ono Pharmaceutical Co. Ltd
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01529619     History of Changes
Other Study ID Numbers: CENA713D1403
First Posted: February 9, 2012    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Alzheimer's disease
Transdermal patch
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents