CompletedPhase 4

Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage AD Having Coexisting svCVD

Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage Alzheimer's Disease Having Coexisting Small Vessel Cerebrovascular Disease

Lead sponsor

National Neuroscience Institute

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

100

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-26

Primary endpoint

•Demonstrated Benefit in Global and Cognitive Measures

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

NCT IDNCT02444637

Org study IDRACE_1.0

Timeline

Milestones

Study start2015-04actual (month precision)

Study first posted2015-05-14estimated

Primary completion2019-03actual (month precision)

Study completion2019-03actual (month precision)

Last update posted2021-03-05actual

Assets

Drug assets

Rivastigmine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age between 50-85 years

•Diagnosis of dementia of the Alzheimer's type according to the National Institute of Ageing-Alzheimer's Association Criteriah

•MRI brain (with T2 or FLAIR sequences) performed within a 12 month period from time of recruitment demonstrating the presence of WMH of ≥2 on the Fazekas scale (Score range of 0-3 wherein a score of 1 indicates mild WMH, 2 indicates moderate WMH and 3 indicates severe WMH).i

•Clinical Dementia Rating score of 1-2j

•Mini-Mental State Examination (MMSE) scores of 12-26 inclusivek

•English or Mandarin speaking, literate participants

Exclusion criteria

•Severe neurological, psychiatric or systemic disease which in the opinion of the clinician could interfere with trial assessments

•The use of any investigational drugs, new psychotropic or dopaminergic agents, cholinesterase inhibitors or anti-cholinergic agents during the 4 weeks prior to recruitment

•Known skin allergy or previous allergic reaction to Rivastigmine patch

Endpoints (2)

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

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame:2 Years

event count, event

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Number of Participants with Demonstrated Benefit in Global and Cognitive Measures

Time frame:2 Years

event count, event

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.