RIVastigmine In Vascular cognitivE Impairment
Condition: Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Exelon (rivastigmine); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules, twice daily orally. Dosage starts at 1.5mg bis diem to 4.5mg bis diem.; Capsule, twice daily orally. Dosage starts at 1.5mg bis diem to 4.5mg bis diem.
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognition; stroke; VCI; VCIND; Cognitive Impairment, No Dementia