Cognitive ImpairmentPhase 4RIVIVENCT00669344
RIVastigmine In Vascular cognitivE Impairment
A Phase 4 study testing Exelon (rivastigmine) in people with Cognitive Impairment, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The study is a 24-week prospective, double blind, randomized, placebo-controlled pilot study of 9 mg / day Rivastigmine in patients with Vascular Cognitive Impairment Not Dementia (CIND) to evaluate efficacy, safety and tolerability in Asian patients. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Exelon (rivastigmine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2006to Feb 2008
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female patients, age 55-85
- outpatients, living with a caregiver
- Rankin score <=3
- Diagnosis of Cognitive Impairment Not Dementia due to cerebrovascular disease
- Post-stroke cognitive impairment
- Cognitive impairment documented by neuropsychological evaluation within 6 months of index stroke
Who cannot join
- Advanced, severe, and unstable disease of any type that may interfere with the efficacy evaluations or put the subject at special risk
- A current diagnosis of active uncontrolled seizure disorder
- A current diagnosis of active peptic ulceration
- A current diagnosis of severe and unstable cardiovascular disease
- A current diagnosis of sick-sinus syndrome or conduction deficits (sino-atrial block, atrioventricular block)
- A current diagnosis of unstable angina
Show all 19Show fewer
- MI within the last 6 months
- DSM IV current diagnosis of dementia
- DSM IV current diagnosis of major depression (patients may be included if currently being treated on an antidepressant and stabilized after 3 months)
- A disability that may prevent the subject from completing all study requirements (e.g. blindness, deafness, severe language difficulty)
- A known exaggerated pharmacological sensitivity or hypersensitivity to acetylcholinesterase inhibitors or to other cholinergic compounds
- Ingestion of any of the following:
- an investigational drug in the past four weeks
- metrifonate in the last 3 months
- a drug or treatment known to cause major organ system toxicity during the past four weeks
- other cholinergic drugs (eg succinylcholine type muscle relaxants) during the past two weeks
- anticholinergics prior to baseline
- acetylcholinesterase inhibitors in the past 3 months
- Women of childbearing potential
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 24-week Prospective, Double Blind, Randomized, Placebo-controlled Pilot Study of 9 mg/Day Rivastigmine in Patients With Vascular Cognitive Impairment Not Dementia to Evaluate Efficacy, Safety and Tolerability in Asian Patients
The study is a 24-week prospective, double blind, randomized, placebo-controlled pilot study of 9 mg / day Rivastigmine in patients with Vascular Cognitive Impairment Not Dementia (CIND) to evaluate efficacy, safety and tolerability in Asian patients. The hypothesis is that patients receiving Rivastigmine would improve in executive functioning domains.
Read the detailed description
Methodology: This is a 24-week, double blind, randomized, placebo-controlled pilot study of 9 mg / day Rivastigmine in patients with Cognitive Impairment Not Dementia due to cerebrovascular disease.
During the screening period, patients will be evaluated for CIND by means of neuropsychological tests establishing cognitive impairment following stroke or resulting from subcortical ischemic vascular disease (diagnosed by MRI) AND exclusion of dementia by DSM-IV criteria. At baseline, eligible patients will be evaluated for additional inclusion/exclusion criteria, vital signs, MMSE, Ten Point Clock Test, Colour Trails Test 1 \& 2, ADAS-Cog, Cognitive Battery, Frontal Assessment Battery (FAB), Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scale for mild cognitive impairment (MCI), Neuropsychiatric Inventory (NPI), Geriatric Depression Scale (GDS) and past/coexistent medical conditions. Laboratory examinations and ECGs will be evaluated at screening and week 24.
Patients will be evaluated every 4 weeks for 12 weeks at which time dose increases will be made and vital signs will be evaluated. At Week 12, cognitive and functional measures will be evaluated including the Ten Point Clock Test, Colour Trails Test 1 \& 2, ADAS-Cog, Cognitive Battery, FAB, ADL Scale for MCI, and NPI and GDS will be evaluated. At week 16 and week 20, telephone calls will be made to patients and caregivers to ascertain compliance. At Week 24, cognitive and functional measures will be evaluated including the Ten Point Clock Test, Colour Trails Test 1 \& 2, ADAS-Cog, Cognitive Battery, FAB, ADL Scale for MCI, and NPI and GDS will be evaluated.
Patients will be receiving a bottle of trial drug at appropriate titration dose every 4 weeks during titration phase starting from rivastigmine/placebo 1.5mg bd daily. During maintenance phase / at week 12, patients will be given 3 bottles of trial drug at the appropriate maintenance dose.
Adverse events and serious adverse events will be captured at every visit. In addition, patients who discontinue the study will be followed for safety evaluations through 24 weeks.
- Conditions
- Cognitive Impairment
- Being tested
- Exelon (rivastigmine), Placebo
- Keywords
- cognition, stroke, VCI, VCIND, Cognitive Impairment, No Dementia
- Medical subject headings
- Cognitive Dysfunction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exelon (rivastigmine)Drug
Capsules, twice daily orally. Dosage starts at 1.5mg bis diem to 4.5mg bis diem.
PlaceboDrug
Capsule, twice daily orally. Dosage starts at 1.5mg bis diem to 4.5mg bis diem.
| Study group | Role | What they receive |
|---|---|---|
| II | Placebo comparator | Placebo Receives: Drug: Placebo |
| I | Experimental | Rivastigmine Receives: Drug: Exelon (rivastigmine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the comparative change from baseline between treatment and placebo arms in the Ten Point Clock Drawing Test as well as Color Trails 1 and 2.
Measured: week 24
Secondary outcomes (4)
To evaluate the comparative change from baseline between treatment and placebo on cognitive function
Measured: week 24
To evaluate the comparative change from baseline between treatment and placebo on activities of daily living
Measured: week 24
To evaluate the comparative change from baseline between treatment and placebo on behavior and depression
Measured: week 24
To evaluate the safety and tolerability of treatment in comparison to placebo
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study startFeb 2006
- Primary completionApr 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, National Neuroscience Institute
- Responsible party
- Sponsor
- Investigators
- Eng King Tan, FAMS, Principal investigator, National Neuroscience Institute, Singapore General Hospital Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669344
- Sponsor's protocol ID
- CENA713BSG01
- Acronym
- RIVIVE
- Status last verified
- Feb 2017
- First submitted
- 28 Apr 2008
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week Prospective, Double Blind, Randomized, Placebo-controlled Pilot Study of 9 mg/Day Rivastigmine in Patients With Vascular Cognitive Impairment Not Dementia to Evaluate Efficacy, Safety and Tolerability in Asian Patients
- ClinicalTrials.gov ID
- NCT00669344
- Acronym / sponsor ID
- RIVIVE / CENA713BSG01
- Conditions
- Cognitive Impairment
- Keywords
- cognition, stroke, VCI, VCIND, Cognitive Impairment, No Dementia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Novartis, National Neuroscience Institute
- Study start
- Feb 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 30 Apr 2008 (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 study is a 24-week prospective, double blind, randomized, placebo-controlled pilot study of 9 mg / day Rivastigmine in patients with Vascular Cognitive Impairment Not Dementia (CIND) to evaluate efficacy, safety and tolerability in Asian patients. The hypothesis is that patients receiving Rivastigmine would improve in executive functioning domains.
Detailed description
Methodology: This is a 24-week, double blind, randomized, placebo-controlled pilot study of 9 mg / day Rivastigmine in patients with Cognitive Impairment Not Dementia due to cerebrovascular disease.
During the screening period, patients will be evaluated for CIND by means of neuropsychological tests establishing cognitive impairment following stroke or resulting from subcortical ischemic vascular disease (diagnosed by MRI) AND exclusion of dementia by DSM-IV criteria. At baseline, eligible patients will be evaluated for additional inclusion/exclusion criteria, vital signs, MMSE, Ten Point Clock Test, Colour Trails Test 1 \& 2, ADAS-Cog, Cognitive Battery, Frontal Assessment Battery (FAB), Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scale for mild cognitive impairment (MCI), Neuropsychiatric Inventory (NPI), Geriatric Depression Scale (GDS) and past/coexistent medical conditions. Laboratory examinations and ECGs will be evaluated at screening and week 24.
Patients will be evaluated every 4 weeks for 12 weeks at which time dose increases will be made and vital signs will be evaluated. At Week 12, cognitive and functional measures will be evaluated including the Ten Point Clock Test, Colour Trails Test 1 \& 2, ADAS-Cog, Cognitive Battery, FAB, ADL Scale for MCI, and NPI and GDS will be evaluated. At week 16 and week 20, telephone calls will be made to patients and caregivers to ascertain compliance. At Week 24, cognitive and functional measures will be evaluated including the Ten Point Clock Test, Colour Trails Test 1 \& 2, ADAS-Cog, Cognitive Battery, FAB, ADL Scale for MCI, and NPI and GDS will be evaluated.
Patients will be receiving a bottle of trial drug at appropriate titration dose every 4 weeks during titration phase starting from rivastigmine/placebo 1.5mg bd daily. During maintenance phase / at week 12, patients will be given 3 bottles of trial drug at the appropriate maintenance dose.
Adverse events and serious adverse events will be captured at every visit. In addition, patients who discontinue the study will be followed for safety evaluations through 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| II | Placebo comparator | Drug: PlaceboPlacebo |
| I | Experimental | Drug: Exelon (rivastigmine)Rivastigmine |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male and female patients, age 55-85
- outpatients, living with a caregiver
- Rankin score <=3
- Diagnosis of Cognitive Impairment Not Dementia due to cerebrovascular disease
- Post-stroke cognitive impairment
Key exclusion criteria (19 listed)
- Advanced, severe, and unstable disease of any type that may interfere with the efficacy evaluations or put the subject at special risk
- A current diagnosis of active uncontrolled seizure disorder
- A current diagnosis of active peptic ulceration
- A current diagnosis of severe and unstable cardiovascular disease
- A current diagnosis of sick-sinus syndrome or conduction deficits (sino-atrial block, atrioventricular block)
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 |
|---|---|---|
| Exelon (rivastigmine)Capsules, twice daily orally. Dosage starts at 1.5mg bis diem to 4.5mg bis diem. | Drug | I |
| PlaceboCapsule, twice daily orally. Dosage starts at 1.5mg bis diem to 4.5mg bis diem. | Drug | II |
Primary outcome
To evaluate the comparative change from baseline between treatment and placebo arms in the Ten Point Clock Drawing Test as well as Color Trails 1 and 2.
Time frame: week 24
4 secondary outcomes
To evaluate the comparative change from baseline between treatment and placebo on cognitive function
Time frame: week 24
To evaluate the comparative change from baseline between treatment and placebo on activities of daily living
Time frame: week 24
To evaluate the comparative change from baseline between treatment and placebo on behavior and depression
Time frame: week 24
To evaluate the safety and tolerability of treatment in comparison to placebo
Time frame: 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 10 Feb 2017.
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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.
Eng King Tan, FAMS principal investigator
National Neuroscience Institute, Singapore General Hospital Campus
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 Exelon (rivastigmine) in people with Cognitive Impairment, run by Singapore General Hospital at 1 site in Singapore.
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 6 inclusion and 19 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 10 Feb 2017. 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 Singapore. 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. Some participants in this study may receive a placebo. 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?
To evaluate the comparative change from baseline between treatment and placebo arms in the Ten Point Clock Drawing Test as well as Color Trails 1 and 2. (time frame: week 24). 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 10 Feb 2017.