Alzheimer's DiseasePhase 3NCT00099242
Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
A Phase 3 study testing rivastigmine transdermal patch in people with Alzheimer's Disease and Dementia, Alzheimer Type, run by Novartis Pharmaceuticals at 75 sites in 21 countries.
Trial summary
The goal of this research study is to evaluate the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease, Dementia, Alzheimer Type
- What is being tested?
- rivastigmine transdermal patch
- How many people
- 1,040 participants
- Where
- 75 sitesin 21 countries
- Study dates
- Nov 2003to Jan 2006
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of dementia of the Alzheimer's type
- Males, and females who are surgically sterile or one year postmenopausal
- A primary caregiver willing to accept responsibility for supervising the treatment
Who cannot join
- Any condition (other than Alzheimer's) that could explain patient's dementia
- An advanced, severe or unstable disease that may put the patient at special risk
- Current diagnosis of active, uncontrolled seizure disorder or unstable cardiovascular disease
Trial locations and contacts
75 sites in 21 countries.
75 sites in 21 countries
United States22 sites
Study site
Austin, Texas, 78756
Study site
Boca Raton, Florida, 33486
Study site
Columbus, Ohio, 43215
Study site
Dayton, Ohio, 45415
Study site
Fort Lauderdale, Florida, 33321
Study site
Greensburg, Pennsylvania, 15601
Study site
Houston, Texas, 77030
Study site
Long Branch, New Jersey, 07740
Study site
Miami, Florida, 33137
Study site
Miami Beach, Florida, 33154
Study site
Nashville, Tennessee, 37203
Study site
Oklahoma City, Oklahoma, 73118
Study site
Omaha, Nebraska, 68131
Study site
Orange, California, 92868-3298
Study site
Port Charlotte, Florida, 33952
Study site
San Francisco, California, 94109
Study site
Snellville, Georgia, 30078
Study site
St Louis, Missouri, 63104
Study site
Tacoma, Washington, 98405
Study site
Toms River, New Jersey, 08755
Study site
West Palm Beach, Florida, 33407
Study site
Whiting, New Jersey, 08759
Czechia5 sites
Study site
Brno
Study site
Brno-Bohunice
Study site
Hradec Králové
Study site
Olomouc
Study site
Prague
Israel5 sites
Study site
Beersheva
Study site
Haifa
Study site
Jerusalem
Study site
Petah Tikva
Study site
Tel Aviv
Poland5 sites
Study site
Gdansk
Study site
Lublin
Study site
Poznan
Study site
Szczecin
Study site
Warsaw
Norway4 sites
Study site
Bodø
Study site
Oslo
Study site
Tromsø
Study site
Trondheim
Sweden4 sites
Study site
Gothenburg
Study site
Kalmar
Study site
Stockholm
Study site
Uppsala
Taiwan4 sites
Study site
Kaohsiung City
Study site
Taichung
Study site
Taipei
Study site
Taoyuan
Denmark3 sites
Study site
Copenhagen
Study site
Glostrup Municipality
Study site
Hillerød
Mexico3 sites
Study site
Guadalajara Jalisco
Study site
Mexico City
Study site
Monterrey Nuevo Leon
South Korea3 sites
Study site
Jungbuk
Study site
KyungKi-province
Study site
Seoul
About this study
The goal of this research study is to evaluate the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease.
- Conditions
- Alzheimer's Disease, Dementia, Alzheimer Type
- Being tested
- rivastigmine transdermal patch
- Keywords
- Alzheimer's Disease, Dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rivastigmine transdermal patchDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognition from baseline at week 24
Global clinical impression of change from baseline at week 24
Secondary outcomes (5)
Change from baseline at week 24 in activities of daily living
Change from baseline at week 24 in behavioral symptoms
Change from baseline at week 24 in global cognitive testing
Change from baseline at week 24 in executive function
Change from baseline at week 24 in attention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2004 (estimated)
- Study startNov 2003
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,040 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099242
- Sponsor's protocol ID
- CENA713D2320
- Status last verified
- Oct 2017
- First submitted
- 10 Dec 2004
- Last updated
- 13 Oct 2017
- Results posted
- No
Publications
Lefevre G, Callegari F, Gsteiger S, Xiong Y. Effects of Renal Impairment on Steady-State Plasma Concentrations of Rivastigmine: A Population Pharmacokinetic Analysis of Capsule and Patch Formulations in Patients with Alzheimer's Disease. Drugs Aging. 2016 Oct;33(10):725-736. doi: 10.1007/s40266-016-0405-y.
PubMed 27681702Alva G, Grossberg GT, Schmitt FA, Meng X, Olin JT. Efficacy of rivastigmine transdermal patch on activities of daily living: item responder analyses. Int J Geriatr Psychiatry. 2011 Apr;26(4):356-63. doi: 10.1002/gps.2534.
PubMed 21312297
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00099242
- Acronym / sponsor ID
- CENA713D2320
- Conditions
- Alzheimer's Disease, Dementia, Alzheimer Type
- Keywords
- Alzheimer's Disease, Dementia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,040 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Jan 2006 (actual)
- First posted
- 10 Dec 2004 (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.
The goal of this research study is to evaluate the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of dementia of the Alzheimer's type
- Males, and females who are surgically sterile or one year postmenopausal
- A primary caregiver willing to accept responsibility for supervising the treatment
Key exclusion criteria (3 listed)
- Any condition (other than Alzheimer's) that could explain patient's dementia
- An advanced, severe or unstable disease that may put the patient at special risk
- Current diagnosis of active, uncontrolled seizure disorder or unstable cardiovascular disease
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 | – |
Primary outcome
Change in cognition from baseline at week 24
Global clinical impression of change from baseline at week 24
5 secondary outcomes
Change from baseline at week 24 in activities of daily living
Change from baseline at week 24 in behavioral symptoms
Change from baseline at week 24 in global cognitive testing
Change from baseline at week 24 in executive function
Change from baseline at week 24 in attention
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 13 Oct 2017.
- Derived from this study: PubMed 27681702Lefevre G, Callegari F, Gsteiger S, Xiong Y. Effects of Renal Impairment on Steady-State Plasma Concentrations of Rivastigmine: A Population Pharmacokinetic Analysis of Capsule and Patch Formulations in Patients with Alzheimer's Disease. Drugs Aging. 2016 Oct;33(10):725-736. doi: 10.1007/s40266-016-0405-y.
- Derived from this study: PubMed 21312297Alva G, Grossberg GT, Schmitt FA, Meng X, Olin JT. Efficacy of rivastigmine transdermal patch on activities of daily living: item responder analyses. Int J Geriatr Psychiatry. 2011 Apr;26(4):356-63. doi: 10.1002/gps.2534.
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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.
The record lists no contact. Use the official record to reach the sponsor.
75 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rivastigmine transdermal patch in people with Alzheimer's Disease and Dementia, Alzheimer Type, run by Novartis Pharmaceuticals at 75 sites in 21 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 3 inclusion and 3 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 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Czechia, Israel, Poland, Norway and 16 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in cognition from baseline at week 24. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00099242, which also lists 2 linked publications.
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 13 Oct 2017.