RIVastigmine In Vascular cognitivE Impairment

NCT00669344 | Completed Phase 4

• 1 other identifier: CENA713BSG01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment

Keywords

cognition; stroke; VCI; VCIND; Cognitive Impairment, No Dementia

Outcome Measures

Primary Outcomes (1)

• 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.

  week 24

Secondary Outcomes (4)

• To evaluate the comparative change from baseline between treatment and placebo on cognitive function

  week 24

• To evaluate the comparative change from baseline between treatment and placebo on activities of daily living

  week 24

• To evaluate the comparative change from baseline between treatment and placebo on behavior and depression

  week 24

• To evaluate the safety and tolerability of treatment in comparison to placebo

  week 24

Study Arms (2)

II

PLACEBO COMPARATOR

Placebo

Drug: Placebo

I

EXPERIMENTAL

Rivastigmine

Drug: Exelon (rivastigmine)

Interventions

Exelon (rivastigmine) DRUG

Capsules, twice daily orally. Dosage starts at 1.5mg bis diem to 4.5mg bis diem.

I

Placebo DRUG

Capsule, twice daily orally. Dosage starts at 1.5mg bis diem to 4.5mg bis diem.

II

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead
• Novartis: collaborator
• National Neuroscience Institute: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Stroke

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Eng King Tan, FAMS

  National Neuroscience Institute, Singapore General Hospital Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2008
• First Posted: April 30, 2008
• Study Start: February 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: February 1, 2008
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

SG (1)