Vascular DementiaPhase 3NCT00099216
Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia
A Phase 3 study testing Rivastigmine in people with Vascular Dementia, run by Novartis Pharmaceuticals at 63 sites in 10 countries.
Trial summary
The goal of this research study is to evaluate the effectiveness, tolerability and safety of rivastigmine capsules in males and females between the ages of 50 and 85 years old with probable vascular dementia. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Vascular Dementia
- What is being tested?
- Rivastigmine
- How many people
- 708 participants
- Where
- 63 sitesin 10 countries
- Study dates
- Aug 2001to Nov 2005
- 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
- Between the ages of 50 and 85 years old
- Have contact with a responsible caregiver 3 or more days per week
- Be male or a female who is surgically sterilized or one year post menopausal
Who cannot join
- Current diagnosis of severe or unstable cardiovascular or other diseases
- Current diagnosis of active, uncontrolled seizure disorder, Parkinson's disease or Alzheimer's disease
Trial locations and contacts
63 sites in 10 countries.
63 sites in 10 countries
United States17 sites
Study site
Albuquerque, New Mexico
Study site
Allentown, Pennsylvania, 18103
Study site
Austin, Texas, 78756
Study site
Bennington, Vermont, 05201
Study site
Boynton Beach, Florida, 33426
Study site
Charleston, South Carolina, 29406
Study site
Des Moines, Iowa, 50314
Study site
Greensburg, Pennsylvania, 15601
Study site
Houston, Texas, 77030
Study site
Indianapolis, Indiana, 46202
Study site
Irvine, California, 92618
Study site
Miami Beach, Florida, 33140
Study site
New York, New York, 10003
Study site
Port Charlotte, Florida
Study site
Portland, Oregon, 97223
Study site
San Francisco, California, 94109
Study site
St Louis, Missouri
Germany9 sites
Study site
Bautzen
Study site
Berlin
Study site
Bochum
Study site
Chemnitz
Study site
Eisenhüttenstadt
Study site
Erlangen
Study site
Freiburg im Breisgau
Study site
Lüdenscheid
Study site
Osnabrück
France7 sites
Study site
Amiens
Study site
Bordeaux
Study site
Lille
Study site
Marseille
Study site
Montpellier
Study site
Toulouse
Study site
Tours
Italy7 sites
Study site
Ancona
Study site
Brescia
Study site
Florence
Study site
Perugia
Study site
Reggio Emilia
Study site
Roma
Study site
Vicenza
United Kingdom7 sites
Study site
Bristol
Study site
Clydebank
Study site
East Sussex
Study site
Lytham St Annes
Study site
Newcastle upon Tyne, Newcastle
Study site
Southampton
Study site
Swindon, Wiltshire
Spain5 sites
Study site
Barakaldo
Study site
Barcelona
Study site
Madrid
Study site
Pamplona
Study site
Saint Cugat Del Valles
Canada4 sites
Study site
Edmonton, Alberta
Study site
Montreal, Quebec
Study site
Ottawa, Ontario
Study site
Toronto, Ontario
About this study
The goal of this research study is to evaluate the effectiveness, tolerability and safety of rivastigmine capsules in males and females between the ages of 50 and 85 years old with probable vascular dementia.
- Conditions
- Vascular Dementia
- Being tested
- Rivastigmine
- Keywords
- Dementia,vascular,rivastigmine,stroke,memory loss
- Medical subject headings
- Dementia, Vascular, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivastigmineDrug
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 (3)
Change in activities of daily living from baseline at week 24
Change in behavioral symptoms from baseline at week 24
Change in clinical staging from baseline at week 24
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 startAug 2001
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular DementiaStudies 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
- 708 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
- NCT00099216
- Sponsor's protocol ID
- CENA713BIA05
- Status last verified
- Nov 2011
- First submitted
- 10 Dec 2004
- Last updated
- 17 Nov 2011
- Results posted
- No
Publications
Ballard C, Sauter M, Scheltens P, He Y, Barkhof F, van Straaten EC, van der Flier WM, Hsu C, Wu S, Lane R. Efficacy, safety and tolerability of rivastigmine capsules in patients with probable vascular dementia: the VantagE study. Curr Med Res Opin. 2008 Sep;24(9):2561-74. doi: 10.1185/03007990802328142. Epub 2008 Jul 31.
PubMed 18674411
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia
- ClinicalTrials.gov ID
- NCT00099216
- Acronym / sponsor ID
- CENA713BIA05
- Conditions
- Vascular Dementia
- Keywords
- Dementia,vascular,rivastigmine,stroke,memory loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 708 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (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 effectiveness, tolerability and safety of rivastigmine capsules in males and females between the ages of 50 and 85 years old with probable vascular dementia.
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)
- Between the ages of 50 and 85 years old
- Have contact with a responsible caregiver 3 or more days per week
- Be male or a female who is surgically sterilized or one year post menopausal
Key exclusion criteria (2 listed)
- Current diagnosis of severe or unstable cardiovascular or other diseases
- Current diagnosis of active, uncontrolled seizure disorder, Parkinson's disease or Alzheimer's 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 | Drug | – |
Primary outcome
Change in cognition from baseline at week 24
Global clinical impression of change from baseline at week 24
3 secondary outcomes
Change in activities of daily living from baseline at week 24
Change in behavioral symptoms from baseline at week 24
Change in clinical staging from baseline at week 24
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 17 Nov 2011.
- Derived from this study: PubMed 18674411Ballard C, Sauter M, Scheltens P, He Y, Barkhof F, van Straaten EC, van der Flier WM, Hsu C, Wu S, Lane R. Efficacy, safety and tolerability of rivastigmine capsules in patients with probable vascular dementia: the VantagE study. Curr Med Res Opin. 2008 Sep;24(9):2561-74. doi: 10.1185/03007990802328142. Epub 2008 Jul 31.
- Click here for further information and to find an investigational site near youLink provided by the sponsor.
Related trials for Vascular Dementia
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
RecruitingObservational study
China HEalthy Aging and Dementia Study (HEAD)
Alzheimer Disease (AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Registry for CADASIL
Cerebral Autosomal Dominant Ateriopathy With Subcortical Infarcts and Leukoencephalopathy
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
63 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivastigmine in people with Vascular Dementia, run by Novartis Pharmaceuticals at 63 sites in 10 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 2 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 17 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Germany, France, Italy, United Kingdom and 5 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 NCT00099216, which also lists 1 linked publication.
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 17 Nov 2011.