CAREER

CompletedPhase NA

Cognitive Changes in Alzheimer's Disease Patients Associated With or Without White Matter Changes After Rivastigmine

Changes of Cognitive Function in Patients With Mild to Moderate Alzheimer's Disease Associated With or Without White Matter Changes After Rivastigmine Patch Therapy - Multi-center, Prospective, Open-label Clinical Trial

Lead sponsor

Dong-A University

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

300

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-26

Primary endpoint

•ADAS-Cog

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 IDNCT01380288

Org study IDneuropark

Timeline

Milestones

Study start2011-06actual (month precision)

Study first posted2011-06-27estimated

Primary completion2016-12actual (month precision)

Study completion2017-12-31actual

Last update posted2018-02-05actual

Assets

Drug assets

Rivastigmine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•AD in NINCDS-ADRDA criteria, mild to moderate

•probable AD with or without mild to moderate whiter matter lesions, excluding multiple large vessel infarcts or a single, strategically placed infarct (angular gyrus, thalamus, basal forebrain, territory of the posterior or anterior cerebral artery) on MRI scan (within 12 months)

•MMSE score : 10 to 26 at screening

•Hachinski scores ≤ 4

•No clinically significant laboratory abnormalities, such as thyroid disease, vitamine B12 deficiency or folic acid deficiency

Exclusion criteria

•Current evidence of history of neurological, psychiatric and other illness that could contribute to dementia

•Subjects with clinical significant cardiovascular disease, stroke, pulmonary disease or any other medical disease in the past 6 months

•History of cancer within the last 5 years

•Subjects with evidence or history of clinically significant allergic reaction to AchEI or drugs

•Subjects who had significant visual or hearing difficulties

Endpoints (7)

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

Caregiver / quality of life

Safety / tolerability / PK

Global cognition

3 endpoints

Primary/protocol endpoint

The changes of cognitive function as measured by ADAS-Cog

Time frame:24 weeks

ADAS-Cog

descriptive

Secondary/protocol endpoint

MMSE (Mini-Mental State Examination)

Time frame:24 weeks

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)

Time frame:24 weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

Time frame:24 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI)

Time frame:24 weeks

Neuropsychiatric Inventory (NPI)

descriptive

Caregiver / quality of life

1 endpoint

Secondary/protocol endpoint

Caregiver burden scale

Time frame:24 weeks

descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Adverse events

Time frame:24 weeks

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Park KW, Kim EJ, Han HJ, Shim YS, Kwon JC, Ku BD, Park KH, Yi HA, Kim KK, Yang DW, Lee HW, Kang H, Kwon OD, Kim S, Lee JH, Chung EJ, Park SW, Park MY, Yoon B, Kim BC, Seo SW, Choi SH. Efficacy and tolerability of rivastigmine patch therapy in patients with mild-to-moderate Alzheimer's dementia associated with minimal and moderate ischemic white matter hyperintensities: A multicenter prospective open-label clinical trial. PLoS One. 2017 Aug 7;12(8):e0182123. doi: 10.1371/journal.pone.0182123.…
PMID28786987via DERIVED

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.