← Trials/Trial dossier/NCT01054976

CompletedPhase 4Results posted

The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease

Lead sponsor

Janssen Korea, Ltd., Korea

Asset

Galantamine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-24

Primary endpoints

•Simple Reaction Time•Choice Reaction Time

Identifiers

Registered as

Org study IDCR015850

Secondary IDGAL-KOR-21Janssen Korea, Ltd., Korea

Secondary IDGALALZ4039Janssen Korea, Ltd., Korea

NCT IDNCT01054976

Timeline

Milestones

Study start2006-10 (month precision)

Primary completion2009-02actual (month precision)

Study completion2009-02actual (month precision)

Study first posted2010-01-22estimated

Last update posted2012-12-24estimated

Results first posted2012-12-24estimated

Assets

Drug assets

Galantamine

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

•Alzheimer's disease according to the criteria of DSM-IV, NINCDS-ADRDA

•K-MMSE (Korean - Mini Mental State Exam) is 10 to 24

•Reliable Guardian available to the patients

•Patient or guardian provided written informed consent before entering into the clinical trial

Exclusion criteria

•Acetylcholine esterase inhibitors used to treat dementia taken within 30 days of the beginning in this clinical trial

•Neurodegenerative diseases (eg Parkinson's disease, Pick's disease, Huntington's disease, Down syndrome)

•Dementia related to head trauma and dementia related to brain damage due to cerebral hypoxia (hypoxic brain damage after cardiopulmonary resuscitation, hypoxic brain damage after surgery, hypoxic brain damage due to addiction, hypoxic brain damage due to shock)

•brain tumor, nerve syphilis, meningitis, encephalitis

•epilepsy

Endpoints (10)

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

Executive function / language

Function / daily living

Global cognition

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)

Time frame:Baseline, Week 12

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)

Time frame:Baseline, Week 12

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Galantaminen=73 Participants	1.31	5.67

Executive function / language

4 endpoints

Primary/protocol endpoint

Change From Baseline in Simple Reaction Time

Time frame:Baseline, Week 12

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline in Choice Reaction Time

Time frame:Baseline, Week 12

change from baseline, improvement

Primary/registry result

Change From Baseline in Simple Reaction Time

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

Group	Value (mean), seconds	Standard deviation
GalantamineWeek 4 (n=83)n=92 Participants	-30.92	1277.0
Week 12 (n=73)n=92 Participants	180.83	519.18

Primary/registry result

Change From Baseline in Choice Reaction Time

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

Group	Value (mean), seconds	Standard deviation
GalantamineWeek 4 (n=80)n=92 Participants	429.54	3388.0
Week 12 (n=73)n=92 Participants	1331	3627.0

Function / daily living

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Korean Version of Disability Assessment for Demential Scale (DAD-K)

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Seoul-Instrumental Activities of Daily Livings (S-IADL)

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/registry result

Change From Baseline in Korean Version of Disability Assessment for Demential Scale (DAD-K)

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Galantaminen=73 Participants	-1.41	10.53

Secondary/registry result

Change From Baseline in Seoul-Instrumental Activities of Daily Livings (S-IADL)

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Galantaminen=73 Participants	1.22	6.88

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.