RIVastigmine In Vascular cognitivE Impairment (RIVIVE)
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|ClinicalTrials.gov Identifier: NCT00669344|
Recruitment Status : Completed
First Posted : April 30, 2008
Last Update Posted : February 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Impairment||Drug: Exelon (rivastigmine) Drug: Placebo||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||February 2008|
Placebo Comparator: II
Capsule, twice daily orally. Dosage starts at 1.5mg bis diem to 4.5mg bis diem.
Drug: Exelon (rivastigmine)
Capsules, twice daily orally. Dosage starts at 1.5mg bis diem to 4.5mg bis diem.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669344
|Singapore General Hospital|
|Singapore, Singapore, 169608|
|Principal Investigator:||Eng King Tan, FAMS||National Neuroscience Institute, Singapore General Hospital Campus|