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

This study is currently recruiting participants.
Verified May 2013 by Novartis
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01529619
First received: February 6, 2012
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Alzheimer's Disease
 Drug: Rivastigmine transdermal patch
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J cog) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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:
  • Adverse Events, Serious Adverse Events, Adverse event leading to discontinuation of study drug [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
    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.

  • Change From Baseline in Disability Assessment for Dementia (DAD) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Japanese version of the Clinical global impression of change (J-CGIC) [ Time Frame: Week 4, 8, 12, 16, 20, 24 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Modified Crichton Scale [ Time Frame: Baseline and Week 4, 8, 12, 16, 20, 24 ] [ Designated as safety issue: No ]

    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


  • Formulation usability questionnaire [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 110
Study Start Date: March 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529619

Contacts
Contact: Novartis Pharmaceuticals +81337978748
Contact: Novartis Pharmaceuticals

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01529619     History of Changes
Other Study ID Numbers: CENA713D1403
Study First Received: February 6, 2012
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
Rivastigmine
Alzheimer's disease
Transdermal patch

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Rivastigmine
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013