Alzheimer's DiseasePhase 4NCT00104442
Study of the Effects of Current Drug Treatments on Levels of Certain Brain Chemicals in Alzheimer's Disease
A Phase 4 study testing Rivastigmine in people with Alzheimer's Disease, run by Novartis at 1 site in United States.
Trial summary
Alzheimer's disease is a medical illness that damages the brain and causes problems with memory, mood and behavior. A substance called acetylcholine (ACh), which is naturally produced in the body, plays an important role in the normal functioning of the brain. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Rivastigmine
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Apr 2006
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of mild to moderate Alzheimer's disease
- Must be able to swallow capsule/tablet
- Must have a caregiver who is available to attend all study visits
Who cannot join
- Digestive problems related to peptic ulcer
- Experienced a heart attack or stroke in the last 6 months
- Serious/unstable asthma or severe pulmonary (lung) disease
- On current treatment with a blood thinner
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Alzheimer's disease is a medical illness that damages the brain and causes problems with memory, mood and behavior. A substance called acetylcholine (ACh), which is naturally produced in the body, plays an important role in the normal functioning of the brain. In subjects with Alzheimer's disease, the level of ACh is greatly reduced. Currently, there are three commonly prescribed drugs used for treating the symptoms of Alzheimer's disease by helping to maintain the level of ACh in the brain. This study will evaluate how much each of these drugs changes the levels of certain brain chemicals that are known to, or may play an important role in, Alzheimer's disease and its symptoms.
- Conditions
- Alzheimer's Disease
- Being tested
- Rivastigmine
- Keywords
- Alzheimer's disease, memory loss, dementia, senility, forgetful, geriatric, behavior, mood swings
- Medical subject headings
- Alzheimer Disease, Memory Disorders, Dementia, Behavior
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.
Changes in specific brain enzyme activity from baseline to week 13
Secondary outcomes (3)
Correlate changes in specific brain enzyme activity at week 13 to cognition and behavior
Changes in levels of protein biomarkers in Alzheimer's disease and neurodegeneration from baseline to week 13
Correlate changes in specific brain enzyme activity after 13 weeks treatment to changes in global functioning at 13 and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2005 (estimated)
- Study startOct 2003
- Study completionApr 2006
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.
- 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
- 80 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104442
- Sponsor's protocol ID
- CENA713BUS25
- Status last verified
- Dec 2007
- First submitted
- 28 Feb 2005
- Last updated
- 21 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Current Drug Treatments on Levels of Certain Brain Chemicals in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00104442
- Acronym / sponsor ID
- CENA713BUS25
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, memory loss, dementia, senility, forgetful, geriatric, behavior, mood swings
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- Apr 2006 (actual)
- First posted
- 1 Mar 2005 (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.
Alzheimer's disease is a medical illness that damages the brain and causes problems with memory, mood and behavior. A substance called acetylcholine (ACh), which is naturally produced in the body, plays an important role in the normal functioning of the brain. In subjects with Alzheimer's disease, the level of ACh is greatly reduced. Currently, there are three commonly prescribed drugs used for treating the symptoms of Alzheimer's disease by helping to maintain the level of ACh in the brain. This study will evaluate how much each of these drugs changes the levels of certain brain chemicals that are known to, or may play an important role in, Alzheimer's disease and its symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of mild to moderate Alzheimer's disease
- Must be able to swallow capsule/tablet
- Must have a caregiver who is available to attend all study visits
Key exclusion criteria (4 listed)
- Digestive problems related to peptic ulcer
- Experienced a heart attack or stroke in the last 6 months
- Serious/unstable asthma or severe pulmonary (lung) disease
- On current treatment with a blood thinner
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
Changes in specific brain enzyme activity from baseline to week 13
3 secondary outcomes
Correlate changes in specific brain enzyme activity at week 13 to cognition and behavior
Changes in levels of protein biomarkers in Alzheimer's disease and neurodegeneration from baseline to week 13
Correlate changes in specific brain enzyme activity after 13 weeks treatment to changes in global functioning at 13 and 26 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 21 Dec 2007.
- Click here for information about study sites in your areaLink provided by the sponsor.
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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.
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 in people with Alzheimer's Disease, run by Novartis at 1 site in United States.
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 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 21 Dec 2007. 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 United States. 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?
Changes in specific brain enzyme activity from baseline to week 13. 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 21 Dec 2007.