RIVastigmine In Vascular cognitivE Impairment (RIVIVE)
Tracking Information | |||||
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First Received Date ICMJE | April 28, 2008 | ||||
Last Updated Date | April 29, 2008 | ||||
Start Date ICMJE | February 2006 | ||||
Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00669344 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | RIVastigmine In Vascular cognitivE Impairment | ||||
Official Title ICMJE | 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 | ||||
Brief 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. The hypothesis is that patients receiving Rivastigmine would improve in executive functioning domains. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Cognitive Impairment | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 50 | ||||
Completion Date | February 2008 | ||||
Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 55 Years to 85 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Singapore | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00669344 | ||||
Other Study ID Numbers ICMJE | CENA713BSG01 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | TAN Eng King/ Principle Investigator, National Neuroscience Institute, Singapore General Hospital Campus | ||||
Study Sponsor ICMJE | Singapore General Hospital | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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Information Provided By | Singapore General Hospital | ||||
Verification Date | April 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |