Cognitive SymptomsPhase 3NCT00134953
Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment
A Phase 3 study testing Rivastigmine in people with Cognitive Symptoms, run by Novartis.
Trial summary
This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Cognitive Symptoms
- What is being tested?
- Rivastigmine
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to May 2004
- 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
- Adult, Older adult
Who may be able to join
- Males or females who are one year post-menopausal or without childbearing potential
- Between the ages of 50 and 85 years old
- Mild cognitive impairment confirmed by Mini Mental State Examination (MMSE) score between 23 and 27
- Cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver, according to the investigator's judgement
Who cannot join
- A current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances or secondary dementia
- A current diagnosis of epilepsy or depression, or any other diagnosis that may interfere with the patient's response to study medication
- An advanced, severe or unstable disease of any type that may interfere with efficacy evaluations
- Other protocol-defined exclusion criteria may apply.
About this study
This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with mild cognitive impairment (MCI).
- Conditions
- Cognitive Symptoms
- Being tested
- Rivastigmine
- Keywords
- Mild cognitive impairment, Alzheimer's disease, Dementia, Mild Cognitive Impairment (MCI)
- Medical subject headings
- Neurobehavioral Manifestations, Cognitive Dysfunction, Alzheimer Disease, 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.
16 week's treatment with rivastigmine on alertness, memory, attention, cognitive flexibility, orientation and language in patients with mild cognitive impairment
Secondary outcomes (1)
Safety of 16 week's treatment with rivastigmine in patients with mild cognitive impairment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startJan 2003
- Study completionMay 2004
Why it stopped: The Principal Investigator left the clinic and there was no one who could take over this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive SymptomsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals Corporation, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134953
- Sponsor's protocol ID
- CENA713BDE05
- Status last verified
- Dec 2007
- First submitted
- 23 Aug 2005
- Last updated
- 17 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT00134953
- Acronym / sponsor ID
- CENA713BDE05
- Conditions
- Cognitive Symptoms
- Keywords
- Mild cognitive impairment, Alzheimer's disease, Dementia, Mild Cognitive Impairment (MCI)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Principal Investigator left the clinic and there was no one who could take over this study.
- Enrolment
- 24 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- May 2004 (actual)
- First posted
- 25 Aug 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.
This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with mild cognitive impairment (MCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females who are one year post-menopausal or without childbearing potential
- Between the ages of 50 and 85 years old
- Mild cognitive impairment confirmed by Mini Mental State Examination (MMSE) score between 23 and 27
- Cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver, according to the investigator's judgement
Key exclusion criteria (4 listed)
- A current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances or secondary dementia
- A current diagnosis of epilepsy or depression, or any other diagnosis that may interfere with the patient's response to study medication
- An advanced, severe or unstable disease of any type that may interfere with efficacy evaluations
- Other protocol-defined 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 | Drug | – |
Primary outcome
16 week's treatment with rivastigmine on alertness, memory, attention, cognitive flexibility, orientation and language in patients with mild cognitive impairment
1 secondary outcome
Safety of 16 week's treatment with rivastigmine in patients with mild cognitive impairment
Results and safety
The study was stopped early (reason given: The Principal Investigator left the clinic and there was no one who could take over this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2007.
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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 Corporation study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivastigmine in people with Cognitive Symptoms, run by Novartis.
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 4 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: stopped early, as of the sponsor's last update on 17 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: The Principal Investigator left the clinic and there was no one who could take over this study.). Results are not available in the source record.
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?
16 week's treatment with rivastigmine on alertness, memory, attention, cognitive flexibility, orientation and language in patients with mild cognitive impairment. 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 17 Dec 2007.