Back to resultsRandomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Active Comparator
ENA713
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Rivastigmine, Alzheimer's disease, Transdermal patch
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 ≥ 10 and ≤ 20 at baseline
Exclusion Criteria:
- Any medical or neurological conditions other than AD that could explain the patient's dementia
- A current diagnosis of probable or possible vascular dementia
- A score of > 5 on the Modified Hachinski Ischemic Scale (MHIS)
- A current DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient's response to study medication.
- Treated with donepezil or galantamine within last 4 weeks before the efficacy assessment at baseline.
- an advanced severe progressive or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient's at special risk
- 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
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- Novartis Investigative Site
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- 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
- 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
- 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 2
Arm Type
Experimental
Active Comparator
Arm Label
1 step
3 step
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation
The primary variable of this study is the percentage of patients having an AE leading to study drug discontinuation during the 24-week double-blind treatment period.
Secondary 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.
Change From Baseline in Mini-Mental State Examination (MMSE)
The MMSE was used to measure severity of Alzheimer's disease. The test consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, sriting ability and reproduction of complex polygons); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.
Number of Participants With Improvement in Japanese Clinical Global Impression of Change (J-CGIC). Patients With "Improvement": a Total of 1. Markedly Improved, 2. Improved, and 3. Slightly
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) and a patient is defined to have improvement if J-CGIC tool the values 1, 2, or 3.
The Percentage of Treatment Retention.
Treatment retention rate at effective dose is defined as the proportion of patients who met all the followings - 1) completed the study, 2) received rivastigmine patch 18 mg/day throughout the last 8 weeks 3) received 18 mg/day for ≥75% of the days during the last 8 weeks
Full Information
NCT ID
NCT01614886
First Posted
June 6, 2012
Last Updated
June 30, 2016
Sponsor
Novartis Pharmaceuticals
Collaborators
Ono Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01614886
Brief Title
Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)
Official Title
A 24-week, Multicenter, Parallel-group, Randomized,Double-blind Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Methods of Rivastigmine Patch (ENA713D/ONO-2540) in Patients With Mild to Moderate Alzheimer's Disease (MMSE 10-20)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
Collaborators
Ono Pharmaceutical Co. Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the tolerability, safety and efficacy of 3-step titration versus 1-step titration of Rivastigmine patch in the Japanese population.
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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 step
Arm Type
Experimental
Arm Title
3 step
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Active Comparator
Intervention Description
1-step titration group begin treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day.
Intervention Type
Drug
Intervention Name(s)
ENA713
Intervention Description
-3-step titration group will begin treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
Primary Outcome Measure Information:
Title
Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation
Description
The primary variable of this study is the percentage of patients having an AE leading to study drug discontinuation during the 24-week double-blind treatment period.
Time Frame
Up to 24 weeks
Secondary 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, 8,16, and 24 weeks
Title
Change From Baseline in Mini-Mental State Examination (MMSE)
Description
The MMSE was used to measure severity of Alzheimer's disease. The test consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, sriting ability and reproduction of complex polygons); 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 24 weeks
Title
Number of Participants With Improvement in Japanese Clinical Global Impression of Change (J-CGIC). Patients With "Improvement": a Total of 1. Markedly Improved, 2. Improved, and 3. Slightly
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) and a patient is defined to have improvement if J-CGIC tool the values 1, 2, or 3.
Time Frame
4, 8, 12,16, 20 and 24 weeks
Title
The Percentage of Treatment Retention.
Description
Treatment retention rate at effective dose is defined as the proportion of patients who met all the followings - 1) completed the study, 2) received rivastigmine patch 18 mg/day throughout the last 8 weeks 3) received 18 mg/day for ≥75% of the days during the last 8 weeks
Time Frame
Up to 24 weeks
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 ≥ 10 and ≤ 20 at baseline
Exclusion Criteria:
Any medical or neurological conditions other than AD that could explain the patient's dementia
A current diagnosis of probable or possible vascular dementia
A score of > 5 on the Modified Hachinski Ischemic Scale (MHIS)
A current DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient's response to study medication.
Treated with donepezil or galantamine within last 4 weeks before the efficacy assessment at baseline.
an advanced severe progressive or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient's at special risk
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
Anjo-city
State/Province
Aichi
ZIP/Postal Code
446-8510
Country
Japan
Facility Name
Novartis Investigative Site
City
Obu-city
State/Province
Aichi
ZIP/Postal Code
474-8511
Country
Japan
Facility Name
Novartis Investigative Site
City
Seto-city
State/Province
Aichi
ZIP/Postal Code
489-8642
Country
Japan
Facility Name
Novartis Investigative Site
City
Toyoake-city
State/Province
Aichi
ZIP/Postal Code
470-1168
Country
Japan
Facility Name
Novartis Investigative Site
City
Akita-city
State/Province
Akita
ZIP/Postal Code
010-0874
Country
Japan
Facility Name
Novartis Investigative Site
City
Chiba-city
State/Province
Chiba
ZIP/Postal Code
260-8712
Country
Japan
Facility Name
Novartis Investigative Site
City
Toon-city
State/Province
Ehime
ZIP/Postal Code
791-0295
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
Fujioka-city
State/Province
Gumma
ZIP/Postal Code
375-0017
Country
Japan
Facility Name
Novartis Investigative Site
City
Hiroshima-city
State/Province
Hiroshima
ZIP/Postal Code
734-8530
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
Kasama-city
State/Province
Ibaraki
ZIP/Postal Code
309-1793
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
212-0016
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
Sagamihara-city
State/Province
Kanagawa
ZIP/Postal Code
252-5188
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
Kochi-city
State/Province
Kochi
ZIP/Postal Code
780-0842
Country
Japan
Facility Name
Novartis Investigative Site
City
Kochi-city
State/Province
Kochi
ZIP/Postal Code
780-8037
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
Kumamoto City
State/Province
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Novartis Investigative Site
City
Kumamoto-city
State/Province
Kumamoto
ZIP/Postal Code
861-8002
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-city
State/Province
Kyoto
ZIP/Postal Code
607-8411
Country
Japan
Facility Name
Novartis Investigative Site
City
Kyoto-city
State/Province
Kyoto
ZIP/Postal Code
616-8255
Country
Japan
Facility Name
Novartis Investigative Site
City
Sendai-city
State/Province
Miyagi
ZIP/Postal Code
982-8523
Country
Japan
Facility Name
Novartis Investigative Site
City
Kitamorokata-gun
State/Province
Miyazaki
ZIP/Postal Code
889-1911
Country
Japan
Facility Name
Novartis Investigative Site
City
Azumino-city
State/Province
Nagano
ZIP/Postal Code
399-8204
Country
Japan
Facility Name
Novartis Investigative Site
City
Matsumoto-city
State/Province
Nagano
ZIP/Postal Code
399-8701
Country
Japan
Facility Name
Novartis Investigative Site
City
Nagaoka-city
State/Province
Niigata
ZIP/Postal Code
940-2302
Country
Japan
Facility Name
Novartis Investigative Site
City
Kurashiki-city
State/Province
Okayama
ZIP/Postal Code
710-0826
Country
Japan
Facility Name
Novartis Investigative Site
City
Okayama-city
State/Province
Okayama
ZIP/Postal Code
700-8607
Country
Japan
Facility Name
Novartis Investigative Site
City
Sakai-city
State/Province
Osaka
ZIP/Postal Code
590-0018
Country
Japan
Facility Name
Novartis Investigative Site
City
Suita-city
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Novartis Investigative Site
City
Suita-city
State/Province
Osaka
ZIP/Postal Code
565-0874
Country
Japan
Facility Name
Novartis Investigative Site
City
Kanzaki-gun
State/Province
Saga
ZIP/Postal Code
842-0192
Country
Japan
Facility Name
Novartis Investigative Site
City
Kasukabe-city
State/Province
Saitama
ZIP/Postal Code
344-0036
Country
Japan
Facility Name
Novartis Investigative Site
City
Kawaguchi-city
State/Province
Saitama
ZIP/Postal Code
333-0832
Country
Japan
Facility Name
Novartis Investigative Site
City
Koshigaya-city
State/Province
Saitama
ZIP/Postal Code
343-0032
Country
Japan
Facility Name
Novartis Investigative Site
City
Saitama-city
State/Province
Saitama
ZIP/Postal Code
338-0003
Country
Japan
Facility Name
Novartis Investigative Site
City
Shizuoka-city
State/Province
Shizuoka
ZIP/Postal Code
420-8688
Country
Japan
Facility Name
Novartis Investigative Site
City
Shizuoka-city
State/Province
Shizuoka
ZIP/Postal Code
424-8636
Country
Japan
Facility Name
Novartis Investigative Site
City
Tokushima-city
State/Province
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Novartis Investigative Site
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Novartis Investigative Site
City
Hachioji-city
State/Province
Tokyo
ZIP/Postal Code
193-0998
Country
Japan
Facility Name
Novartis Investigative Site
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
136-0075
Country
Japan
Facility Name
Novartis Investigative Site
City
Musashino-city
State/Province
Tokyo
ZIP/Postal Code
180-8610
Country
Japan
Facility Name
Novartis Investigative Site
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
143-0016
Country
Japan
Facility Name
Novartis Investigative Site
City
Tachikawa-city
State/Province
Tokyo
ZIP/Postal Code
190-8531
Country
Japan
Facility Name
Novartis Investigative Site
City
Shimonoseki-city
State/Province
Yamaguchi
ZIP/Postal Code
752-8510
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)
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