Trial · NCT00623103
Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)
NCT00623103, Phase 3, Completed, Novartis; results first posted 2011-11-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD). Trials, record NCT00623103. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00623103
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)
- NCT number
- NCT00623103
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 583 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Parkinson's Disease Dementia
- Interventions
- Rivastigmine capsule, Rivastigmine transdermal patch
- First posted
- 2008-02-25
- Last updated
- 2011-11-28
- Results first posted
- 2011-11-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) | 76 Weeks | The AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall)in each treatment group. The 95% CIs associated with the rates were also presented. |
| Primary | Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) | 76 Weeks | The discontinuations due to these AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall) in each treatment group. The 95% CIs associated with these rates were also presented. |
| Secondary | Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline | From Baseline to Weeks 8, 16, 24, 52 and 76 | Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). Part III records the motor examination in Items 18-31 rated on a scale of 0 to 4 with (0 being absent/ normal and 4 being the worse) for a total possible score of 0 to 56. |
| Secondary | Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline | From Baseline to Weeks 16, 24, 52 and 76 | Mattis DRS-2 is a measure of cognitive status. The total score is the sum of 5 subscale scores: Attention \[0-37\], Initiation/Perservation \[0-37\] (performing alternating movements), Construction \[0-6\] (copying designs), Conceptualization \[0-39\] (similarities) and Memory \[0-25\] (sentence recall, design recognition)for a total possible score of 0-144. Higher score is reflective of better cognitive function, lower scores associated with more pronounced cognitive deficit. The change from baseline was calculated such that a positive number indicates an improvement. |
| Secondary | Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline | From Baseline to Weeks 16, 24, 52 and 76 | The Ten Point Clock Test measures executive functioning and visuospatial skills. Participants are asked to put numbers on the face of a clock and then make the clock read 10 minutes after 11. Points are awarded on a scale of 0 to 10 for spacing of specific numbers and the positions of the hands. The change from baseline was calculated such that a positive number indicates improvement. |
| Secondary | Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline | At Week 16, 24, 52 and 76 (or early discontinuation) | The parameter for analysis was the change from baseline of total score of 10 items on the NPI scale (NPI-10). The total score is a sum of the 10 domains, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and all domains were equally weighted for total score(thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score patient can get). The change from baseline was calculated such that a negative number indicates an improvement (symptom reduction). |
| Secondary | Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline | From Baseline to Week 16, 24, 52 and 76 (or early discontinuation) | The 23 item caregiver-based ADL scale of the dementia Alzheimer's disease Cooperative Study-Activities of Daily Living (ADCS-ADL) was used for analysis. This is a caregiver rated questionnaire of 23 items, with possible scores over a range of 0-78, where 78 denote full functioning with no impairment. The total score was derived by adding up the item scores of the 23 items. The change from baseline was calculated such that a positive change indicates an improvement. |
| Secondary | UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation) | From Baseline to Week 8, 16, 24, 52 and 76 (or early discontinuation) | Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). UPDRS Part V is assessed by the modified Hoehn and Yahr Staging Scale. The scale ranges from 0 (no signs of disease) to 5 (wheelchair bound or bedridden unless aided). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) | 76 Weeks | Safety Population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. Participants with observation at 76 weeks were included in this analysis. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) | 76 Weeks | Safety Population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. Participants with observation at 76 weeks were included in this analysis. | Percentage of participants | NUMBER |
| SECONDARY | Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline | From Baseline to Weeks 8, 16, 24, 52 and 76 | Safety population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. n in each of the categories is the number of participants at each time point with non-missing baseline and post-baseline measurements. | Score on a scale | MEAN |
| SECONDARY | Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline | From Baseline to Weeks 16, 24, 52 and 76 | Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF) | Score on a scale | MEAN |
| SECONDARY | Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline | From Baseline to Weeks 16, 24, 52 and 76 | Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF) | Score on a scale | MEAN |
| SECONDARY | Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline | At Week 16, 24, 52 and 76 (or early discontinuation) | Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF) | Score | MEAN |
| SECONDARY | Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline | From Baseline to Week 16, 24, 52 and 76 (or early discontinuation) | Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF). | Score | MEAN |
| SECONDARY | UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation) | From Baseline to Week 8, 16, 24, 52 and 76 (or early discontinuation) | The Safety population consisted of all patients who have received at least one dose of study drug and have had at least 1 safety measurement after baseline. n=indicates patients with observation during different timepoints. | Score | MEAN |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) | Rivastigmine Capsule | Tremor | 24.5 | 95% Confidence Interval 19.7 to 29.8 | Percentage of participants |
| Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) | Rivastigmine Patch | Tremor | 9.7 | 95% Confidence Interval 6.6 to 13.7 | Percentage of participants |
| Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) | Rivastigmine Capsule | Muscle Rigidity | 4.1 | 95% Confidence Interval 2.1 to 7.0 | Percentage of participants |
| Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) | Rivastigmine Patch | Muscle Rigidity | 5.2 | 95% Confidence Interval 2.9 to 8.4 | Percentage of participants |
| Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) | Rivastigmine Capsule | Bradykinesia | 5.1 | 95% Confidence Interval 2.9 to 8.3 | Percentage of participants |
| Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) | Rivastigmine Patch | Bradykinesia | 6.3 | 95% Confidence Interval 3.7 to 9.7 | Percentage of participants |
| Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) | Rivastigmine Capsule | Fall | 17.0 | 95% Confidence Interval 12.9 to 21.8 | Percentage of participants |
| Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) | Rivastigmine Patch | Fall | 20.1 | 95% Confidence Interval 15.7 to 25.2 | Percentage of participants |
| Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) | Rivastigmine Capsule | Tremor | 2.4 | 95% Confidence Interval 1.0 to 4.8 | Percentage of participants |
| Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) | Rivastigmine Patch | Tremor | 0.7 | 95% Confidence Interval 0.1 to 2.5 | Percentage of participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rivastigmine Capsule | 295 | |
| Overall Study | STARTED | Rivastigmine Patch | 288 | |
| Overall Study | Safety Set: Received Study Drug | Rivastigmine Capsule | 294 | |
| Overall Study | Safety Set: Received Study Drug | Rivastigmine Patch | 288 | |
| Overall Study | COMPLETED | Rivastigmine Capsule | 184 | |
| Overall Study | COMPLETED | Rivastigmine Patch | 175 | |
| Overall Study | NOT COMPLETED | Rivastigmine Capsule | 111 | |
| Overall Study | NOT COMPLETED | Rivastigmine Patch | 113 |
Source ClinicalTrials.gov
Adverse events416
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Exelon Capsule | 21 | 294 | |
| other | Constipation | Gastrointestinal disorders | Exelon Patch | 21 | 288 | |
| other | Diarrhoea | Gastrointestinal disorders | Exelon Capsule | 27 | 294 | |
| other | Diarrhoea | Gastrointestinal disorders | Exelon Patch | 14 | 288 | |
| other | Nausea | Gastrointestinal disorders | Exelon Capsule | 117 | 294 | |
| other | Nausea | Gastrointestinal disorders | Exelon Patch | 23 | 288 | |
| other | Vomiting | Gastrointestinal disorders | Exelon Capsule | 45 | 294 | |
| other | Vomiting | Gastrointestinal disorders | Exelon Patch | 7 | 288 | |
| other | Application site erythema | General disorders | Exelon Capsule | 0 | 294 | |
| other | Application site erythema | General disorders | Exelon Patch | 40 | 288 |
1 to 10 of 416Source ClinicalTrials.gov
See all 416 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Exelon Capsule | ||
| Total, all-cause mortality | Exelon Patch | ||
| Total, other adverse events | Exelon Capsule | 239 | 294 |
| Total, other adverse events | Exelon Patch | 215 | 288 |
| Total, serious adverse events | Exelon Capsule | 87 | 294 |
| Total, serious adverse events | Exelon Patch | 83 | 288 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Exelon Capsule vs Exelon Patch: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00623103
GET https://conductscience.org/api/trials/v1/NCT00623103/results?page=2