RIVIVE

CompletedPhase 4

RIVastigmine In Vascular cognitivE Impairment

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

Lead sponsor

Singapore General Hospital

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Vascular cognitive impairment / dementia

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Comparative change from baseline between treatment

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCENA713BSG01

NCT IDNCT00669344

Timeline

Milestones

Study start2006-02 (month precision)

Primary completion2007-04actual (month precision)

Study completion2008-02actual (month precision)

Study first posted2008-04-30estimated

Last update posted2017-02-10actual

Assets

Drug assets

Rivastigmine

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Behavior / neuropsychiatric

Safety / tolerability / PK

Other (unclassified)

Global cognition

1 endpoint

Secondary/protocol endpoint

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

Time frame:week 24

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

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

Time frame:week 24

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

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

Time frame:week 24

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

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

Time frame:week 24

descriptive

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

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

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.