Alzheimer's DiseasePhase 4KAPANCT00549601
Convenience, Tolerability, and Safety of Change in the Administration of Rivastigmine From Capsules to a Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease
A Phase 4 study testing Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day), Rivastigmine patch (9.5 mg/day) and Rivastigmine capsules (6 mg to 12 mg/day) in people with Alzheimer's Disease, run by Novartis at 1 site in Spain.
Trial summary
This study used two doses of rivastigmine transdermal patch (5 cm^2, 10 cm^2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3 mg bid (bis in die, twice a day), 4,5 mg bid, 6 mg bid) to rivastigmine transdermal… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day), Rivastigmine patch (9.5 mg/day) and Rivastigmine capsules (6 mg to 12 mg/day)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2007to Apr 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet DSM-IV (Diagnostic \& Statistical Manual of Mental Disorders, Version IV) criteria for dementia of Alzheimer type and NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria for probable Alzheimer's disease (AD), have a MMSE (Mini Mental State Examination) score > 10 and < 26
- Have received continuous treatment with rivastigmine capsules at least with 3 mg bid (6 mg of total daily dose) for at least 3 months before entering in the study
- Cooperative, willing to complete all aspects of the study, and capable of doing so, either alone or with the aid of a responsible caregiver
- Have a primary caregiver willing to accept responsibility for supervising the treatment, (eg, application and removal of the patch daily at approximately the same time of day) and assessing the condition of the patient throughout the study.
Who cannot join
- A medical or neurological condition other that AD that could explain the patients dementia (eg, Huntington's disease, Parkinson's Disease, abnormal thyroid function test, B12 or folate deficiency, post-traumatic conditions, syphilis)
- Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application)
- History of allergy to topical products containing vitamin E
- Taken any of the following substances prior to randomization:
- succinylcholine-type muscle relaxants during the previous 2 weeks
- an investigational drug during the previous 4 weeks
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomised, Open-label Study to Evaluate Convenience and Safety of Change in the Mode of Administration of Rivastigmine (From Capsules to a Transdermal Patch) in Patients With Alzheimer's Disease
This study used two doses of rivastigmine transdermal patch (5 cm^2, 10 cm^2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3 mg bid (bis in die, twice a day), 4,5 mg bid, 6 mg bid) to rivastigmine transdermal patch and to assess safety, tolerability, convenience, and caregivers preferences of rivastigmine transdermal patch versus capsules.
- Conditions
- Alzheimer's Disease
- Being tested
- Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day), Rivastigmine patch (9.5 mg/day), Rivastigmine capsules (6 mg to 12 mg/day)
- Keywords
- Alzheimer's, rivastigmine, transdermal, safety, randomized, switch, patch
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)Drug
Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
Rivastigmine patch (9.5 mg/day)Drug
Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
Rivastigmine capsules (6 mg to 12 mg/day)Drug
Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day) | Experimental | Not described Receives: Drug: Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day) |
| Rivastigmine patch (9.5 mg/day) | Experimental | Not described Receives: Drug: Rivastigmine patch (9.5 mg/day) |
| Rivastigmine capsules (6 mg to 12 mg/day) | Active comparator | Not described Receives: Drug: Rivastigmine capsules (6 mg to 12 mg/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study
Gastrointestinal adverse events (including nausea, vomiting, and diarrhea) were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT).
Measured: Baseline to end of study (Month 3)
Secondary outcomes (5)
Percentage of Patients With an AE Involving the Skin (Local Tolerance) Recorded Over the Course of the Study Period (Patch Groups Only)
Adverse events involving the skin included urticaria, pruritus, erythema, and pigmentation disorder. Only the groups administered rivastigmine transdermally via patch were analyzed. The adverse events were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT).
Measured: Baseline to end of study (Month 3)
Percentage of Patients With at Least 1 AE of Any Kind Recorded During the Period of the Study.
Adverse events were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT). They were also tabulated by severity, relationship with study treatment, and action taken.
Measured: Baseline to end of study (Month 3)
Overall Caregiver Satisfaction With Treatment
Caregivers were asked to rate their overall degree of satisfaction with the Alzheimer's disease treatment on a scale of 1 to 5 (1 "Very good" - 5 "Very poor") at the end of the study (Month 3). A higher score indicates less satisfaction.
Measured: At end of study (Month 3)
Overall Patient Satisfaction With Treatment
Patients were asked to rate their overall degree of satisfaction with the Alzheimer's disease treatment on a scale of 1 to 5 (1 "Very good" - 5 "Very poor") at the end of the study (Month 3). A higher score indicates less satisfaction.
Measured: At end of study (Month 3)
Change in the Total Mini-Mental State Examination (MMSE) Score From Baseline to Month 1 and Month 3
The Mini Mental State Examination (MMSE) was used to evaluate the patient's cognitive status and how it progressed over time. The 35-point version used in this study was made up of five sections: orientation, fixation, attention and calculation, memory and language, and constructional praxis. The total score for each patient was obtained by adding the score from each of the above sections. The individual receives 1 point for each correct answer. The total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.
Measured: Baseline to Month 1 and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, MD, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549601
- Sponsor's protocol ID
- CENA713DES07
- Acronym
- KAPA
- Status last verified
- Feb 2011
- First submitted
- 24 Oct 2007
- Last updated
- 24 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomised, Open-label Study to Evaluate Convenience and Safety of Change in the Mode of Administration of Rivastigmine (From Capsules to a Transdermal Patch) in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00549601
- Acronym / sponsor ID
- KAPA / CENA713DES07
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's, rivastigmine, transdermal, safety, randomized, switch, patch
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 26 Oct 2007 (estimated)
- Results
- Posted 24 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study used two doses of rivastigmine transdermal patch (5 cm^2, 10 cm^2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3 mg bid (bis in die, twice a day), 4,5 mg bid, 6 mg bid) to rivastigmine transdermal patch and to assess safety, tolerability, convenience, and caregivers preferences of rivastigmine transdermal patch versus capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day) | Experimental | Drug: Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day) |
| Rivastigmine patch (9.5 mg/day) | Experimental | Drug: Rivastigmine patch (9.5 mg/day) |
| Rivastigmine capsules (6 mg to 12 mg/day) | Active comparator | Drug: Rivastigmine capsules (6 mg to 12 mg/day) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet DSM-IV (Diagnostic \& Statistical Manual of Mental Disorders, Version IV) criteria for dementia of Alzheimer type and NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria for probable Alzheimer's disease (AD), have a MMSE (Mini Mental State Examination) score > 10 and < 26
- Have received continuous treatment with rivastigmine capsules at least with 3 mg bid (6 mg of total daily dose) for at least 3 months before entering in the study
- Cooperative, willing to complete all aspects of the study, and capable of doing so, either alone or with the aid of a responsible caregiver
- Have a primary caregiver willing to accept responsibility for supervising the treatment, (eg, application and removal of the patch daily at approximately the same time of day) and assessing the condition of the patient throughout the study.
Key exclusion criteria (7 listed)
- A medical or neurological condition other that AD that could explain the patients dementia (eg, Huntington's disease, Parkinson's Disease, abnormal thyroid function test, B12 or folate deficiency, post-traumatic conditions, syphilis)
- Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application)
- History of allergy to topical products containing vitamin E
- Taken any of the following substances prior to randomization:
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months). | Drug | Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day) |
| Rivastigmine patch (9.5 mg/day)Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment). | Drug | Rivastigmine patch (9.5 mg/day) |
| Rivastigmine capsules (6 mg to 12 mg/day)Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment. | Drug | Rivastigmine capsules (6 mg to 12 mg/day) |
Primary outcome
Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study
Time frame: Baseline to end of study (Month 3)
Gastrointestinal adverse events (including nausea, vomiting, and diarrhea) were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT).
5 secondary outcomes
Percentage of Patients With an AE Involving the Skin (Local Tolerance) Recorded Over the Course of the Study Period (Patch Groups Only)
Time frame: Baseline to end of study (Month 3)
Percentage of Patients With at Least 1 AE of Any Kind Recorded During the Period of the Study.
Time frame: Baseline to end of study (Month 3)
Overall Caregiver Satisfaction With Treatment
Time frame: At end of study (Month 3)
Overall Patient Satisfaction With Treatment
Time frame: At end of study (Month 3)
Change in the Total Mini-Mental State Examination (MMSE) Score From Baseline to Month 1 and Month 3
Time frame: Baseline to Month 1 and Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals, MD study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day), Rivastigmine patch (9.5 mg/day) and Rivastigmine capsules (6 mg to 12 mg/day) in people with Alzheimer's Disease, run by Novartis at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study (time frame: Baseline to end of study (Month 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2011.