CompletedPhase 4

The Efficacy of Galantamine on the Attention and the Frontal Function of the Patients With Dementia of Alzheimer Type

A Prospective, Open-labeled, Multicenter Study of Galantamine on the Attention and Frontal Function of the Patients With Dementia of Alzheimer Type

Lead sponsor

Janssen Korea, Ltd., Korea

Asset

Galantamine

Listed sites

Recruiting sites

Enrollment

102

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-26

Primary endpoint

•Attention and Executive function

Identifiers

Registered as

Org study IDCR005047

NCT IDNCT00216515

Timeline

Milestones

Study start2004-03 (month precision)

Study first posted2005-09-22estimated

Study completion2005-11actual (month precision)

Last update posted2011-01-24estimated

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

•Male or female patients aged 50 years or older

•Alzheimer's disease according to the criteria of DSM-IV15, NINCDS-ADRDA16

•Measuring standard MMSE-K 10 to 26

•Patients who are literate

•Dementia patients being nursed by the family

•Patients who submitted written consent before entering into the clinical trial (the guardian consent is also effective)

Exclusion criteria

•If the patient was taking AChEI (Tacrine, Donepezil, Rivastigmine) to treat dementia, the patient can enter into this clinical trial as long as he/she has not taken the drug within 15 days of the beginning of the clinical trial

•Neurodegenerative diseases (e.g. 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, brain tumor

•amentia

•epilepsy

•major psychiatric patients such as major depression and schizophrenia

•treatment-resistant gastric and peptic ulcer

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

•patients complaining of severe difficulty in urination

•patients who have undergone heart surgery within 6 months or patients who experienced myocardial infarction, patients with untreated congestive heart failure, patients with severe disorders in the mitral valve or aortic valve

•patients who have once taken the investigational drugs within the past 1 month from the beginning day of the clinical trial

•patients with uncontrolled diabetes mellitus (if the patient is taking medication and consults the doctor on a regular basis, he/she can participate in this clinical trial)

•patients who experienced hypersensitivity or allergy by a cholinesterase inhibitor

•patients who have not given their consent to the clinical trial, patients who are judged inappropriate to participate in this clinical trial by the investigator

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

Global cognition

Executive function / language

Global cognition

1 endpoint

Secondary/protocol endpoint

Cognition: Mini-Mental Sate Examination-Korean version (MMSE-K);Activities of Daily living: Seoul- Instrumental Activities of daily livings (S-IADL);Behavior: NPI-Q;Global Change: Global Deterioration Scale (GDS)

Mini-Mental State Examination (MMSE)

ratio, descriptive

Executive function / language

1 endpoint

Primary/protocol endpoint

Attention and Executive function: Visual CPT, Visual Span, Color Trail Making test, Stroop test

descriptive

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.