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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Rivastigmine transdermal patch
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Rivastigmine, Alzheimer's disease, Transdermal patch

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rivastigmine 18 mg

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
February 6, 2012
Last Updated
November 16, 2016
Sponsor
Novartis Pharmaceuticals
Collaborators
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01529619
Brief Title
Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease Switched From Cholinesterase Inhibitors
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 Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
Collaborators
Ono Pharmaceutical Co. Ltd

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Rivastigmine, Alzheimer's disease, Transdermal patch

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rivastigmine 18 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rivastigmine transdermal patch
Primary Outcome Measure Information:
Title
Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J cog)
Description
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.
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Adverse Events, Serious Adverse Events, Adverse event leading to discontinuation of study drug
Description
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.
Time Frame
Week 24
Title
Change From Baseline in Disability Assessment for Dementia (DAD)
Description
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.
Time Frame
Baseline and Week 24
Title
Change From Baseline in Mini-Mental State Examination (MMSE)
Description
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.
Time Frame
Baseline and Week 24
Title
Change From Baseline in Japanese version of the Clinical global impression of change (J-CGIC)
Description
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).
Time Frame
Week 4, 8, 12, 16, 20, 24
Title
Change From Baseline in Modified Crichton Scale
Description
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
Time Frame
Baseline and Week 4, 8, 12, 16, 20, 24
Title
Formulation usability questionnaire
Description
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.
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Nagoya-city
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka-city
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Novartis Investigative Site
City
Miyoshi-city
State/Province
Hiroshima
ZIP/Postal Code
728-0013
Country
Japan
Facility Name
Novartis Investigative Site
City
Ohtake
State/Province
Hiroshima
ZIP/Postal Code
739-0696
Country
Japan
Facility Name
Novartis Investigative Site
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Novartis Investigative Site
City
Kamakura-city
State/Province
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan
Facility Name
Novartis Investigative Site
City
Kawasaki-city
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-0811
Country
Japan
Facility Name
Novartis Investigative Site
City
Koshi-city
State/Province
Kumamoto
ZIP/Postal Code
861-1116
Country
Japan
Facility Name
Novartis Investigative Site
City
Kyoto-city
State/Province
Kyoto
ZIP/Postal Code
600-8558
Country
Japan
Facility Name
Novartis Investigative Site
City
Kyoto
ZIP/Postal Code
606-0851
Country
Japan

12. IPD Sharing Statement

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

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