CompletedResults posted

A Study to Show That the Change of Attention Measure is Correlated With the Changes of Caregiver's Burden After Treatment With Galantamine in Patients With Alzheimer's Disease

An Observational, Multi-Center Study to Demonstrate That the Change of Attention Measure is Correlated With the Changes of Caregiver's Burden After Treatment With Galantamine in Patients With Alzheimer's Disease

Lead sponsor

Janssen Korea, Ltd., Korea

Asset

Galantamine

Listed sites

Recruiting sites

Enrollment

1,882

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-24

Primary endpoints

•Attention Questionnaire Scores (AQS)•Burden Interview (BI) Scores

Identifiers

Registered as

Org study IDCR100958

Secondary IDGAL-KOR-024Janssen Korea, Ltd., Korea

Secondary IDGALALZ4045Janssen Korea, Ltd., Korea

NCT IDNCT01734395

Timeline

Milestones

Study start2007-03 (month precision)

Primary completion2008-01actual (month precision)

Study completion2008-01actual (month precision)

Study first posted2012-11-27estimated

Last update posted2013-08-05estimated

Results first posted2013-08-05estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Alzheimer's disease according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), National Institute of Neurological and Communicative Diseases and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)

•Measuring standard: K-MMSE is 10 to 24

•Patient with reliable Guardian

Exclusion criteria

•Patients with brain tumor, nerve syphilis, meningitis, encephalitis, epilepsy

•Major psychiatric patients such as major depression and schizophrenia

•Patients with treatment-resistant gastric and peptic ulcer

•Patients with clinically serious hepatic, renal, lung, endocrinal or metabolic disease (thyroid, parathyroid, pituitary, renal failure, diabetes mellitus)

Endpoints (6)

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

Executive function / language

Caregiver / quality of life

Global cognition

2 endpoints

Secondary/protocol endpoint

Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE)

Time frame:Baseline, Week 16

Mini-Mental State Examination (MMSE)

descriptive

Secondary/registry result

Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE)

Time frame:Baseline, Week 16

Mini-Mental State Examination (MMSE)

descriptive

Posted result

Group	Value (mean), Units on a scale	Standard deviation
Galantaminen=1393 Participants	-0.69	2.43

Mean Difference (Final Values)-0.6995% CI-0.814 - -0.5586p<.0001t-test, 2 sided

Executive function / language

2 endpoints

Primary/protocol endpoint

Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS)

Time frame:Baseline (Week 1 [Day 1]), Week 16

change from baseline, improvement

Primary/registry result

Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS)

Time frame:Baseline (Week 1 [Day 1]), Week 16

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
Galantaminen=1393 Participants	-1.19	4.56

Mean Difference (Final Values)-1.1995% CI-1.4262 - -0.9467p<.0001t-test, 2 sided

Caregiver / quality of life

2 endpoints

Primary/protocol endpoint

Change From Baseline at Week 16 in Burden Interview (BI) Scores

Time frame:Baseline, Week 16

change from baseline, improvement

Primary/registry result

Change From Baseline at Week 16 in Burden Interview (BI) Scores

Time frame:Baseline, Week 16

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
Galantaminen=1393 Participants	1.48	10.69

Mean Difference (Final Values)1.4895% CI0.9188 - 2.0438p<.0001t-test, 2 sided

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

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.