A Phase 4 interventional study of Exelon (rivastigmine) and Placebo in Cognitive Impairment, sponsored by Singapore General Hospital. Completed at 1 site in Singapore. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-02-10.
Sponsored by Singapore General Hospital · Phase 4, Interventional, and Treatment
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.
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 50 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Singapore General Hospital is the lead sponsor of 266 studies on the registry; 57 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo
Drug: Placebo
Rivastigmine
Drug: Exelon (rivastigmine)
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.
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
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Singapore General Hospital