Trial Outcomes & Findings for Clinical Effectiveness of 10 cm^2 Rivastigmine Patch in Patients With Alzheimer's Disease (NCT NCT00561392)
NCT ID: NCT00561392
Last Updated: 2012-04-16
Results Overview
Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver.
COMPLETED
PHASE4
208 participants
Baseline to Week 24
2012-04-16
Participant Flow
Participant milestones
| Measure |
Rivastigmine 5 and 10 cm^2 Patch
For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability.
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|---|---|
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Overall Study
STARTED
|
208
|
|
Overall Study
COMPLETED
|
155
|
|
Overall Study
NOT COMPLETED
|
53
|
Reasons for withdrawal
| Measure |
Rivastigmine 5 and 10 cm^2 Patch
For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability.
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|---|---|
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Overall Study
Adverse Event
|
38
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Administrative problems
|
4
|
Baseline Characteristics
Clinical Effectiveness of 10 cm^2 Rivastigmine Patch in Patients With Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Rivastigmine 5 and 10 cm^2 Patch
n=208 Participants
For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability.
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|---|---|
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Age Continuous
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74 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
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110 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
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208 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.
Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver.
Outcome measures
| Measure |
Rivastigmine 5 and 10 cm^2 Patch
n=182 Participants
For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability.
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|---|---|
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Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Who Completed the Study
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74.2 Percentage of participants
Interval 67.8 to 80.5
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PRIMARY outcome
Timeframe: Baseline to Week 24Population: The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.
Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver.
Outcome measures
| Measure |
Rivastigmine 5 and 10 cm^2 Patch
n=182 Participants
For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability.
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|---|---|
|
Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Regardless Whether They Completed the Study
|
80.8 Percentage of participants
Interval 75.0 to 86.5
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.
Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver.
Outcome measures
| Measure |
Rivastigmine 5 and 10 cm^2 Patch
n=182 Participants
For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability.
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|---|---|
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Percentage of Participants Who Were Compliant to the 10 cm^2 Patch
|
95.0 Percentage of participants
Standard Deviation 28.3
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SECONDARY outcome
Timeframe: Baseline and Week 24Population: The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.
The MMSE is a brief, practical 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.
Outcome measures
| Measure |
Rivastigmine 5 and 10 cm^2 Patch
n=182 Participants
For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability.
|
|---|---|
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Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 24
|
1.3 Units on a scale
Standard Deviation 3.8
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SECONDARY outcome
Timeframe: Baseline to Week 24Population: The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.
The Trail-making test is a neuropsychological test of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive numbers (1,2,3, etc.) on a sheet of paper or computer screen. The goal of the subject is to finish the test as quickly as possible, and the time taken to complete the test is used as the primary performance metric (in seconds). The maximum time allowed is 300 seconds. A negative change score indicates improvement.
Outcome measures
| Measure |
Rivastigmine 5 and 10 cm^2 Patch
n=182 Participants
For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability.
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|---|---|
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Mean Change From Baseline in the Trail-making Test Part A Score at Week 24
|
-8.9 Seconds
Standard Deviation 109.45
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SECONDARY outcome
Timeframe: Baseline to Week 24Population: The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.
The ADCS-ADL scale is composed of 23 items developed to assess a patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, as well as making judgments and decisions. Responses for each item will be obtained from the caregiver through an interview. The range for the total ADCS-ADL score is 0 to 78; a higher score indicates a more self-sufficient individual. A positive change score indicates improvement.
Outcome measures
| Measure |
Rivastigmine 5 and 10 cm^2 Patch
n=182 Participants
For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability.
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|---|---|
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Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score at Week 24
|
1.3 Units on a scale
Standard Deviation 12.02
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SECONDARY outcome
Timeframe: Baseline to Week 24Population: The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.
The ADCS-CGIC is an assessment tool to make a judgment of change in a patient's condition. Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study. Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline. Results are reported as number of patients in the indicated change category.
Outcome measures
| Measure |
Rivastigmine 5 and 10 cm^2 Patch
n=182 Participants
For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability.
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|---|---|
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Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician
No change
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47 Participants
|
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Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician
Minimal improvement
|
25 Participants
|
|
Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician
Moderate improvement
|
23 Participants
|
|
Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician
Marked improvement
|
15 Participants
|
|
Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician
Minimal decline
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37 Participants
|
|
Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician
Moderate decline
|
12 Participants
|
|
Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician
Marked decline
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline t0 Week 24Population: The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.
The ADCS-CGIC is an assessment tool to make a judgment of change in a patient's condition. Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study. Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline.
Outcome measures
| Measure |
Rivastigmine 5 and 10 cm^2 Patch
n=182 Participants
For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability.
|
|---|---|
|
Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver
No change
|
21 Participants
|
|
Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver
Minimal improvement
|
23 Participants
|
|
Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver
Moderate improvement
|
16 Participants
|
|
Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver
Marked improvement
|
15 Participants
|
|
Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver
Minimal decline
|
56 Participants
|
|
Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver
Moderate decline
|
20 Participants
|
|
Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver
Marked decline
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.
The Mini-Zarit Inventory assesses the burden of a caregiver in caring for a patient. The inventory is composed of 5 questions which are rated according to the following answers: 0 = never, ½ = sometimes, 1 = often. The ratings on the 5 questions are added together resulting in a total score of 0 to 7 with a higher score indicating greater caregiver burden. A negative change score indicates reduced burden.
Outcome measures
| Measure |
Rivastigmine 5 and 10 cm^2 Patch
n=182 Participants
For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability.
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|---|---|
|
Mean Change From Baseline in the Mini-Zarit Inventory Score of Caregiver Burden at Week 24
|
0.4 Units on a scale
Standard Deviation 1.58
|
Adverse Events
Rivastigmine 5 and 10 cm^2 Patch
Serious adverse events
| Measure |
Rivastigmine 5 and 10 cm^2 Patch
n=208 participants at risk
For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability.
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|---|---|
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Cardiac disorders
Bradycardia
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0.48%
1/208
|
|
General disorders
Death
|
0.48%
1/208
|
|
General disorders
Fatigue
|
0.48%
1/208
|
|
General disorders
Malaise
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0.48%
1/208
|
|
Infections and infestations
Bronchitis
|
0.48%
1/208
|
|
Injury, poisoning and procedural complications
Fall
|
0.48%
1/208
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.48%
1/208
|
|
Investigations
Blood glucose abnormal
|
0.48%
1/208
|
|
Metabolism and nutrition disorders
Dehydration
|
0.48%
1/208
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.48%
1/208
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.48%
1/208
|
|
Nervous system disorders
Cerebrovascular accident
|
0.48%
1/208
|
|
Nervous system disorders
Cognitive disorder
|
0.48%
1/208
|
|
Nervous system disorders
Dementia Alzheimer's type
|
1.4%
3/208
|
|
Nervous system disorders
Dysstasis
|
0.48%
1/208
|
|
Nervous system disorders
Grand mal convulsion
|
0.48%
1/208
|
|
Nervous system disorders
Syncope
|
0.48%
1/208
|
|
Psychiatric disorders
Aggression
|
0.48%
1/208
|
|
Psychiatric disorders
Confusional state
|
0.96%
2/208
|
|
Psychiatric disorders
Disorientation
|
0.48%
1/208
|
|
Psychiatric disorders
Psychotic disorder
|
0.48%
1/208
|
|
Renal and urinary disorders
Incontinence
|
0.48%
1/208
|
|
Vascular disorders
Circulatory collapse
|
0.48%
1/208
|
|
Vascular disorders
Deep vein thrombosis
|
0.48%
1/208
|
|
Vascular disorders
Hypertensive crisis
|
0.48%
1/208
|
Other adverse events
| Measure |
Rivastigmine 5 and 10 cm^2 Patch
n=208 participants at risk
For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
10.1%
21/208
|
|
Gastrointestinal disorders
Vomiting
|
7.2%
15/208
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.7%
18/208
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.2%
17/208
|
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER