Alzheimer's DiseasePhase 4EXTRANCT00622713
A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (EXTRA)
A Phase 4 study testing Rivastigmine transdermal patch in people with Alzheimer's Disease, run by Novartis at 1 site in France.
Trial summary
This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm^2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting 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
- How many people
- 228 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Jan 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 50 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Males, and females of at least 50 years old with a primary caregiver
- Probable Alzheimer's disease
- Mini-Mental State Examination (MMSE) score of ≥ 10 and ≤ 26
- Patients initiating therapy for the first time with a Cholinesterase (ChE) inhibitor (patients prescribed both rivastigmine and memantine are allowed) or patients who failed to benefit from previous ChE inhibitor treatment
- Residing with someone in the community throughout the study or, if living alone, in contact with the responsible caregiver everyday
Who cannot join
- Patients not treated according to the product monograph for capsules
- 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 any of the constituents of the patches
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE 10-26)
This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm^2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting
- Conditions
- Alzheimer's Disease
- Being tested
- Rivastigmine transdermal patch
- Keywords
- Alzheimer's disease, cholinesterase inhibitor, rivastigmine
- 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
Also called Exelon, Prometax
The study treatment was delivered as a patch sizes 5 and 10 cm^2 containing respectively 9 and 18 mg of rivastigmine. During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Achieved and Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8 Weeks During 24 Weeks Study
The primary endpoint was the percentage of patients who were able to tolerate (and stay on for at least 8 weeks) rivastigmine target patch size 10 cm^2.
Measured: 24 weeks
Secondary outcomes (4)
Clinical Global Impression of Change (CGI-C) by Physician
The CGIC is an assessment tool used by a clinician to make a judgment of the severity or a change of a patient's condition. The clinician relies solely on information obtained from the patient at the Baseline visit as well as clinical information obtained throughout the study period. The CGIC is rated on the following seven-point scale:"very much improved", "much improved", "slightly improved", "unchanged", "slightly worsened", "much worsened" and "very much worsened".
Measured: Baseline and week 24
Mean Change From Baseline to Week 24 in the 4-item Instrumental Activities of Daily Living (4-IADL) Score
The 4-IADL assesses the ability of a patient to autonomously perform 4 activities of daily living: Use the telephone, take medications, use public transport, and manage their own budget. Each activity is assessed by a series of questions and rated on a scale of 1 to 4. Scores on the 4 activities are combined for a total score ranging from 1 to 16. A lower score indicates a more self-sufficient individual. A positive change from baseline score indicates worsening.
Measured: Baseline to week 24
Mean Change From Baseline to Week 24 in the Mini-Mental State Examination (MMSE) Score
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 from 0 to 30, with higher scores indicating better function. A positive change score indicates improvement from baseline.
Measured: Baseline to week 24
Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score
The Mini-Zarit Inventory assesses the burden of a caregiver in caring for a patient. The inventory is composed of 5 questions which are rated according to the following answers: 0 = never, ½ = sometimes, 1 = often. The ratings on the 5 questions are added together resulting in a total score of 0 to 7 with a higher score indicating greater caregiver burden.
Measured: Baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionJan 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharma S.A.S., Principal investigator, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622713
- Sponsor's protocol ID
- CENA713DFR08
- Other IDs
- N° EudraCT : 2007-003405-27
- Acronym
- EXTRA
- Status last verified
- Jun 2011
- First submitted
- 14 Feb 2008
- Last updated
- 26 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE 10-26)
- ClinicalTrials.gov ID
- NCT00622713
- Acronym / sponsor ID
- EXTRA / CENA713DFR08
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, cholinesterase inhibitor, rivastigmine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Posted 26 Jul 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 is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm^2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males, and females of at least 50 years old with a primary caregiver
- Probable Alzheimer's disease
- Mini-Mental State Examination (MMSE) score of ≥ 10 and ≤ 26
- Patients initiating therapy for the first time with a Cholinesterase (ChE) inhibitor (patients prescribed both rivastigmine and memantine are allowed) or patients who failed to benefit from previous ChE inhibitor treatment
- Residing with someone in the community throughout the study or, if living alone, in contact with the responsible caregiver everyday
Key exclusion criteria (4 listed)
- Patients not treated according to the product monograph for capsules
- 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 any of the constituents of the patches
- 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 patchAlso: Exelon, PrometaxThe study treatment was delivered as a patch sizes 5 and 10 cm^2 containing respectively 9 and 18 mg of rivastigmine. During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2. | Drug | – |
Primary outcome
Percentage of Patients Who Achieved and Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8 Weeks During 24 Weeks Study
Time frame: 24 weeks
The primary endpoint was the percentage of patients who were able to tolerate (and stay on for at least 8 weeks) rivastigmine target patch size 10 cm^2.
4 secondary outcomes
Clinical Global Impression of Change (CGI-C) by Physician
Time frame: Baseline and week 24
Mean Change From Baseline to Week 24 in the 4-item Instrumental Activities of Daily Living (4-IADL) Score
Time frame: Baseline to week 24
Mean Change From Baseline to Week 24 in the Mini-Mental State Examination (MMSE) Score
Time frame: Baseline to week 24
Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score
Time frame: Baseline to week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 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 Pharma S.A.S. principal investigator
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 transdermal patch in people with Alzheimer's Disease, run by Novartis at 1 site in France.
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 5 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 26 Jul 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 France. 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 26 Jul 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 Achieved and Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8 Weeks During 24 Weeks Study (time frame: 24 weeks). 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 26 Jul 2011.