Trial Outcomes & Findings for A 24-Week Efficacy, Safety and Tolerability of Rivastigmine Patch Study in Patients With Probable Alzheimer's Disease (NCT NCT01399125)
NCT ID: NCT01399125
Last Updated: 2014-08-04
Results Overview
The Alzheimer's Disease Assessment Scale (ADAS) is a performance-based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. It was assessed by a mental health professional (e.g., M.D., Ph.D., Pharm.D., R.N., or other equivalent qualifications) with a minimum of 2 years research experience meeting certification requirements.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
501 participants
Primary outcome timeframe
Change at 24 weeks
Results posted on
2014-08-04
Participant Flow
Participant milestones
| Measure |
Rivastigmine Patch
Once-daily target patch size 10 cm²
|
Rivastigmine Capsules
Twice-daily target dose of 6 mg oral capsule
|
|---|---|---|
|
Overall Study
STARTED
|
248
|
253
|
|
Overall Study
Per Protocol (PP) Population
|
192
|
188
|
|
Overall Study
COMPLETED
|
197
|
193
|
|
Overall Study
NOT COMPLETED
|
51
|
60
|
Reasons for withdrawal
| Measure |
Rivastigmine Patch
Once-daily target patch size 10 cm²
|
Rivastigmine Capsules
Twice-daily target dose of 6 mg oral capsule
|
|---|---|---|
|
Overall Study
Adverse Event
|
32
|
30
|
|
Overall Study
Abnormal Lab values
|
0
|
1
|
|
Overall Study
Unsatisfactory Therapeutic Effect
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
8
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Administrative Problems
|
7
|
11
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Protocol Deviation
|
5
|
2
|
Baseline Characteristics
A 24-Week Efficacy, Safety and Tolerability of Rivastigmine Patch Study in Patients With Probable Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Rivastigmine Patch
n=248 Participants
Once-daily target patch size 10 cm²
|
Rivastigmine Capsules
n=253 Participants
Twice-daily target dose of 6 mg oral capsule
|
Total
n=501 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.4 years
STANDARD_DEVIATION 8.02 • n=5 Participants
|
69.8 years
STANDARD_DEVIATION 8.20 • n=7 Participants
|
70.1 years
STANDARD_DEVIATION 8.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change at 24 weeksPopulation: Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.
The Alzheimer's Disease Assessment Scale (ADAS) is a performance-based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. It was assessed by a mental health professional (e.g., M.D., Ph.D., Pharm.D., R.N., or other equivalent qualifications) with a minimum of 2 years research experience meeting certification requirements.
Outcome measures
| Measure |
Rivastigmine Patch
n=192 Participants
Once-daily target patch size 10 cm²
|
Rivastigmine Capsules
n=188 Participants
Twice-daily target dose of 6 mg oral capsule
|
|---|---|---|
|
Change From Baseline on Cognition, Assessed by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
|
-0.5 Scores on a scale
Standard Deviation 6.70
|
-0.7 Scores on a scale
Standard Deviation 6.74
|
SECONDARY outcome
Timeframe: Change at 24 weeksPopulation: Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.
Alzheimer's disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) scale provides a single global rating of change from baseline. It was recommended that the baseline interview be conducted by two raters, one designated as the primary rater, the other as a backup. Both raters were independent trained clinicians, experienced in the assessment of patients with dementia. Neither rater was involved in any other way with the patients' treatment or evaluation throughout the study. At baseline, both raters had access to all of the patient's available records and evaluations. Subsequently, for all ratings of change from baseline, the rater relied solely on information obtained during the baseline interview of the patient and caregiver, including written notes and, if available, the baseline interview audio- or videotape. The rater had no access to any other safety or efficacy data, including all previous post-baseline ADCS-CGIC ratings by either rater.
Outcome measures
| Measure |
Rivastigmine Patch
n=192 Participants
Once-daily target patch size 10 cm²
|
Rivastigmine Capsules
n=188 Participants
Twice-daily target dose of 6 mg oral capsule
|
|---|---|---|
|
Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC)
marked improvement
|
1 participants
|
1 participants
|
|
Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC)
Moderate improvement
|
10 participants
|
12 participants
|
|
Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC)
Minimal improvement
|
68 participants
|
59 participants
|
|
Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC)
No change
|
67 participants
|
74 participants
|
|
Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC)
Moderate worsening
|
7 participants
|
6 participants
|
|
Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC)
Marked worsening
|
1 participants
|
0 participants
|
|
Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC)
Minimal worsening
|
38 participants
|
35 participants
|
SECONDARY outcome
Timeframe: Change at 24 weeksPopulation: Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) is a caregiver-based Activities of Daily Living (ADL) scale composed of 23 items developed for use in dementia clinical studies. It was designed to assess the 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 were obtained from the caregiver through an interview. For each basic ADL, there was a forced choice of best response or a "yes" or "no" question with additional sub questions. Higher numbered scores and answers of "yes" reflected a more self-sufficient individual. Therefore, the higher total score, the higher functioning the patient was. The total score was the sum of all items and sub questions. The range for the total ADCS-ADL score was 0 to 78.
Outcome measures
| Measure |
Rivastigmine Patch
n=192 Participants
Once-daily target patch size 10 cm²
|
Rivastigmine Capsules
n=188 Participants
Twice-daily target dose of 6 mg oral capsule
|
|---|---|---|
|
Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Total Score
|
-1.9 scores on a scale
Standard Deviation 11.02
|
-1.7 scores on a scale
Standard Deviation 11.31
|
SECONDARY outcome
Timeframe: Change at 24 weeksPopulation: Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.
NPI including Caregiver Distress Scale (NPI-D) assesses a wide range of behavior problems encountered in dementia patients to provide a means of distinguishing frequency and severity of changes in behavioral problems \& facilitates rapid behavioral assessment using screening questions.10 behavioral problems \& 2 neurovegetative domains were evaluated through an interview of the caregiver by a mental health professional. The scale includes both frequency \& severity ratings of ea. domain as well as a composite domain score(frequency x severity). Frequency: 1(occasionally) - 4(very frequently)\&severity:1(mild) - 3(marked).The sum of the composite scores of the 12 domains yields the NPI total score. The NPI-D: 0(not severe \& not at all distressing) - 5 (very severe or extremely distressing) for each of the 12 domains. NPI-12 total score: from 0-144, the NPI-10 total score: from 0-120, \& NPI-D score: from 0-60, all with higher scores indicating more severe behavioral disturbance.
Outcome measures
| Measure |
Rivastigmine Patch
n=192 Participants
Once-daily target patch size 10 cm²
|
Rivastigmine Capsules
n=188 Participants
Twice-daily target dose of 6 mg oral capsule
|
|---|---|---|
|
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score
NPI-12: Total score (frequency x severity)
|
-1.3 scores on a scale
Standard Deviation 11.22
|
-1.3 scores on a scale
Standard Deviation 11.98
|
|
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score
NPI-10: Total score (frequency x severity)
|
-1.2 scores on a scale
Standard Deviation 9.84
|
-1.3 scores on a scale
Standard Deviation 10.46
|
|
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score
NPI-D: Distress score (frequency x severity)
|
-0.4 scores on a scale
Standard Deviation 5.65
|
-0.6 scores on a scale
Standard Deviation 5.88
|
SECONDARY outcome
Timeframe: Change at 24 weeksPopulation: Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.
The Mini-Mental State Examination (MMSE) was used to establish patient's eligibility for the study and it was also used as an efficacy parameter in the Double-blind Treatment Period. The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 30, with higher scores indicating betterfunction. The total MMSE score at screening was between 10 and 20, inclusive, in order forthe patient to be eligible to participate in the trial.
Outcome measures
| Measure |
Rivastigmine Patch
n=192 Participants
Once-daily target patch size 10 cm²
|
Rivastigmine Capsules
n=188 Participants
Twice-daily target dose of 6 mg oral capsule
|
|---|---|---|
|
Change From Baseline in Mini-Mental State Examination (MMSE) Total Score
|
0.7 scores on a scale
Standard Deviation 3.31
|
0.7 scores on a scale
Standard Deviation 3.30
|
Adverse Events
Rivastigmine Patch
Serious events: 16 serious events
Other events: 82 other events
Deaths: 0 deaths
Rivastigmine Capsule
Serious events: 21 serious events
Other events: 111 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rivastigmine Patch
n=247 participants at risk
Once-daily target patch size 10 cm²
|
Rivastigmine Capsule
n=251 participants at risk
Twice-daily target dose of 6 mg oral capsule
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.40%
1/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.40%
1/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.40%
1/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.40%
1/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.40%
1/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Cardiac disorders
Cardiac failure
|
0.40%
1/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.00%
0/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.40%
1/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.40%
1/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.00%
0/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.40%
1/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.40%
1/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.40%
1/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.00%
0/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.40%
1/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.80%
2/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.40%
1/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.40%
1/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.00%
0/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Infections and infestations
Appendicitis
|
0.40%
1/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.00%
0/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Infections and infestations
Bronchitis
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.80%
2/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Infections and infestations
Lung infection
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.40%
1/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.40%
1/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.40%
1/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.40%
1/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.00%
0/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.80%
2/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.40%
1/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.00%
0/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.40%
1/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.40%
1/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.00%
0/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.40%
1/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.80%
2/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.40%
1/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.00%
0/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.40%
1/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Nervous system disorders
Cerebral infarction
|
0.40%
1/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.00%
0/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Nervous system disorders
Diabetic coma
|
0.40%
1/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.00%
0/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Psychiatric disorders
Anorexia nervosa
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.40%
1/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Renal and urinary disorders
Dysuria
|
0.40%
1/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.00%
0/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.40%
1/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.81%
2/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.00%
0/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.40%
1/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.40%
1/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.00%
0/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Vascular disorders
Hypertension
|
0.00%
0/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
0.80%
2/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
Other adverse events
| Measure |
Rivastigmine Patch
n=247 participants at risk
Once-daily target patch size 10 cm²
|
Rivastigmine Capsule
n=251 participants at risk
Twice-daily target dose of 6 mg oral capsule
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
5/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
3.2%
8/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Gastrointestinal disorders
Nausea
|
8.1%
20/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
12.7%
32/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
19/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
12.4%
31/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
General disorders
Application site pruritus
|
10.9%
27/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
2.8%
7/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Injury, poisoning and procedural complications
Medication error
|
4.0%
10/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
2.8%
7/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Investigations
Weight decreased
|
4.0%
10/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
6.8%
17/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.5%
16/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
14.7%
37/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Nervous system disorders
Dizziness
|
6.1%
15/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
10.0%
25/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Nervous system disorders
Somnolence
|
2.4%
6/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
4.4%
11/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
|
Psychiatric disorders
Insomnia
|
3.2%
8/247
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
1.6%
4/251
In participant Flow 248 patients (Rivastigmine Patch) and 253 patients (Rivastigmine Capsules) were randomized. For the Adverse Events the Safety (SAF) population: patients who received at least one dose of study drug, and had at least one post-baseline safety assessment was analyzed there fore 247 and 251 patients respectively
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 8627788300
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. 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 pooled data (i.e.,data from all sites) in clinical trial.
- Publication restrictions are in place
Restriction type: OTHER