Alzheimer's DiseasePhase 4CARENCT00731224
Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease.
A Phase 4 study testing Rivastigmine transdermal patch in people with Alzheimer's Disease, run by Novartis Pharmaceuticals at 40 sites in 5 countries.
Trial summary
This study will evaluate compliance, tolerability, safety, efficacy and caregiver burden of rivastigmine patch 10 cm² treatment in people with Alzheimer's disease (MMSE 10-26) initiating therapy for the first time with a cholinesterase inhibitor, and in patients who were unresponsive to previous cholinesterase… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Rivastigmine transdermal patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 40 sitesin 5 countries
- Study dates
- Jul 2008to Oct 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria;
- MMSE score of ≥10 and ≤ 26;
Who cannot join
- Bradycardia (beats per minute less than 50)
- Body weight less than 40 kg;
- Hypersensitivity to cholinesterase inhibitors.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
40 sites in 5 countries.
40 sites in 5 countries
Turkey (Türkiye)18 sites
Novartis Investigative Site
Altunizade, 34662
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Ankara, Turkey, 06500
Novartis Investigative Site
Antalya, 07070
Novartis Investigative Site
Atakum / Samsun, 55139
Novartis Investigative Site
Bursa, Turkey, 16059
Novartis Investigative Site
Emek / Ankara, 06510
Novartis Investigative Site
Etlik / Ankara, 06018
Novartis Investigative Site
Istanbul, 34093
Novartis Investigative Site
Istanbul, 34303
Novartis Investigative Site
Izmir, Turkey, 35040
Novartis Investigative Site
Izmir, 35340
Novartis Investigative Site
Kocaeli, 41380
Novartis Investigative Site
Konya, Turkey, 42080
Novartis Investigative Site
Mersin, 33079
Novartis Investigative Site
Meselik / Eskisehir, 26480
Novartis Investigative Site
Talas / Kayseri, 38039
Novartis Investigative Site
Uskudar / Istanbul, 34668
Australia11 sites
Novartis Investigative Site
Adelaide, South Australia, 5000
Novartis Investigative Site
Ballarat, Victoria, 3353
Novartis Investigative Site
Chemside, Queensland, 4032
Novartis Investigative Site
East Gosford, New South Wales, 2250
Novartis Investigative Site
Fitzroy, Victoria, 3065
Novartis Investigative Site
Gosford, New South Wales, 2250
Novartis Investigative Site
Heidelberg, Victoria, 3081
Novartis Investigative Site
Hornsby, New South Wales, 2077
Novartis Investigative Site
Nedlands, WA 6009
Novartis Investigative Site
Randwick, New South Wales, 2031
Novartis Investigative Site
Woodville, South Australia, 5011
Malaysia5 sites
Novartis Investigative Site
Ipoh, Perak, 30990
Novartis Investigative Site
Johor Bahru, Johor, 81100
Novartis Investigative Site
Kuala Lumpur, Selangor, 50586
Novartis Investigative Site
Kuala Lumpur, 59100
Novartis Investigative Site
Seremban, Negeri Sembilan, 70300
South Korea3 sites
Novartis Investigative Site
Bundang, Seongnam, 463-707
Novartis Investigative Site
Seoul, Korea, 110 744
Novartis Investigative Site
Seoul, 143-729
Thailand3 sites
Novartis Investigative Site
Bangkok, 10330
Novartis Investigative Site
Bangkok, 10400
Novartis Investigative Site
Bangkok, 10700
About this study
Official title: A 24-week, Multi-center, Open-label Evaluation of Compliance and Tolerability of the Once-daily 10 cm² Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease.
This study will evaluate compliance, tolerability, safety, efficacy and caregiver burden of rivastigmine patch 10 cm² treatment in people with Alzheimer's disease (MMSE 10-26) initiating therapy for the first time with a cholinesterase inhibitor, and in patients who were unresponsive to previous cholinesterase inhibitor treatment in a community setting.
- Conditions
- Alzheimer's Disease
- Being tested
- Rivastigmine transdermal patch
- Keywords
- Alzheimer's disease, rivastigmine, 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 transdermal patchDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Rivastigmine transdermal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who can reach the target rivastigmine patch size of 10 cm2 and stay on it for at least 8 weeks.
Measured: At week 24
Secondary outcomes (2)
Mini-Mental State Examination (MMSE), Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL), Global Deterioration Scale (GDS), caregiver burden (Zarit Burden Interview).
Measured: At baseline, wk 12 and wk 24
Patient compliance (drug accounting)
Measured: During 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731224
- Sponsor's protocol ID
- CENA713DAU01
- Acronym
- CARE
- Status last verified
- Mar 2017
- First submitted
- 5 Aug 2008
- Last updated
- 28 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week, Multi-center, Open-label Evaluation of Compliance and Tolerability of the Once-daily 10 cm² Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT00731224
- Acronym / sponsor ID
- CARE / CENA713DAU01
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, rivastigmine, patch
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate compliance, tolerability, safety, efficacy and caregiver burden of rivastigmine patch 10 cm² treatment in people with Alzheimer's disease (MMSE 10-26) initiating therapy for the first time with a cholinesterase inhibitor, and in patients who were unresponsive to previous cholinesterase inhibitor treatment in a community setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rivastigmine transdermal patch |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria;
- MMSE score of ≥10 and ≤ 26;
Key exclusion criteria (4 listed)
- Bradycardia (beats per minute less than 50)
- Body weight less than 40 kg;
- Hypersensitivity to cholinesterase inhibitors.
- Other protocol-defined inclusion/exclusion criteria may apply
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 transdermal patch | Drug | 1 |
Primary outcome
Proportion of patients who can reach the target rivastigmine patch size of 10 cm2 and stay on it for at least 8 weeks.
Time frame: At week 24
2 secondary outcomes
Mini-Mental State Examination (MMSE), Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL), Global Deterioration Scale (GDS), caregiver burden (Zarit Burden Interview).
Time frame: At baseline, wk 12 and wk 24
Patient compliance (drug accounting)
Time frame: During 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
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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 study director
Novartis Pharmaceuticals
40 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivastigmine transdermal patch in people with Alzheimer's Disease, run by Novartis Pharmaceuticals at 40 sites in 5 countries.
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 2 inclusion and 4 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 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Turkey (Türkiye), Australia, Malaysia, South Korea, Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients who can reach the target rivastigmine patch size of 10 cm2 and stay on it for at least 8 weeks. (time frame: At week 24). 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 28 Mar 2017.