RIVastigmine In Vascular cognitivE Impairment (RIVIVE)

This study has been completed.
Sponsor:
Collaborators:
Novartis
National Neuroscience Institute
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT00669344
First received: April 28, 2008
Last updated: April 29, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Cognitive Impairment
Drug: Exelon (rivastigmine)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To evaluate the comparative change from baseline between treatment and placebo on cognitive function [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • To evaluate the comparative change from baseline between treatment and placebo on activities of daily living [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • To evaluate the comparative change from baseline between treatment and placebo on behavior and depression [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of treatment in comparison to placebo [ Time Frame: week 24 ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: February 2006
Study Completion Date: February 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: II
Placebo
Drug: Placebo
Capsule, twice daily orally. Dosage starts at 1.5mg bis diem to 4.5mg bis diem.
Experimental: I
Rivastigmine
Drug: Exelon (rivastigmine)
Capsules, twice daily orally. Dosage starts at 1.5mg bis diem to 4.5mg bis diem.

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.

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669344

Locations
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
Novartis
National Neuroscience Institute
Investigators
Principal Investigator: Eng King Tan, FAMS National Neuroscience Institute, Singapore General Hospital Campus
  More Information

No publications provided

Responsible Party: TAN Eng King/ Principle Investigator, National Neuroscience Institute, Singapore General Hospital Campus
ClinicalTrials.gov Identifier: NCT00669344     History of Changes
Other Study ID Numbers: CENA713BSG01
Study First Received: April 28, 2008
Last Updated: April 29, 2008
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Singapore General Hospital:
cognition
stroke
VCI
VCIND
Cognitive Impairment, No Dementia

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014