- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01529619
Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease Switched From Cholinesterase Inhibitors
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Kyoto, Japan, 606-0851
- Novartis Investigative Site
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Aichi
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Nagoya-city, Aichi, Japan, 467-8602
- Novartis Investigative Site
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Fukuoka
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Fukuoka-city, Fukuoka, Japan, 814-0180
- Novartis Investigative Site
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Hiroshima
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Miyoshi-city, Hiroshima, Japan, 728-0013
- Novartis Investigative Site
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Ohtake, Hiroshima, Japan, 739-0696
- Novartis Investigative Site
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Kagawa
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Kita-gun, Kagawa, Japan, 761-0793
- Novartis Investigative Site
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Kanagawa
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Kamakura-city, Kanagawa, Japan, 247-8533
- Novartis Investigative Site
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Kawasaki-city, Kanagawa, Japan, 216-8511
- Novartis Investigative Site
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Yokohama, Kanagawa, Japan, 241-0811
- Novartis Investigative Site
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Kumamoto
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Koshi-city, Kumamoto, Japan, 861-1116
- Novartis Investigative Site
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Kyoto
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Kyoto-city, Kyoto, Japan, 600-8558
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J cog)
Time Frame: Baseline and Week 24
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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.
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Baseline and Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events, Serious Adverse Events, Adverse event leading to discontinuation of study drug
Time Frame: Week 24
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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.
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Week 24
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Change From Baseline in Disability Assessment for Dementia (DAD)
Time Frame: Baseline and Week 24
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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.
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Baseline and Week 24
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Change From Baseline in Mini-Mental State Examination (MMSE)
Time Frame: Baseline and Week 24
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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.
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Baseline and Week 24
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Change From Baseline in Japanese version of the Clinical global impression of change (J-CGIC)
Time Frame: Week 4, 8, 12, 16, 20, 24
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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).
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Week 4, 8, 12, 16, 20, 24
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Change From Baseline in Modified Crichton Scale
Time Frame: Baseline and Week 4, 8, 12, 16, 20, 24
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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 |
Baseline and Week 4, 8, 12, 16, 20, 24
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Formulation usability questionnaire
Time Frame: Week 24
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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.
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Week 24
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Neuroprotective Agents
- Protective Agents
- Cholinesterase Inhibitors
- Rivastigmine
Other Study ID Numbers
- CENA713D1403
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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