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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Alzheimer's Disease

Treatments: Drug: Galantamine

Study type: Observational

Funder types: Industry

Identifiers

NCT01734395

CR100958

GALALZ4045 (Other Identifier)

GAL-KOR-024 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to demonstrate that the change of attention measure is correlated with the changes of caregiver's burden after treatment with galantamine.

Full description

This is an open-label (all people know the identity of the intervention), prospective (in which the participants are first identified and then followed forward as time passes), observational (study in which the investigators/ physicians observe the patients and measure their outcomes), multi-center (study conducted at multiple sites) study. The study mainly consists of 2 phases including, the screening phase (14 days before administration of study medication) and treatment phase (16 weeks). In the treatment phase, patients will receive galantamine 8 mg/day for the first 4 weeks and later on the dose will be increased up to 24mg (if tolerable). Safety evaluations will include assessment of adverse events. The total duration of the study will be 18 weeks.

Enrollment: 1,882 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,882 participants in 1 patient group

Galantamine

Description:

Patients will receive galantamine 8 mg/day for the first 4 weeks and the dose of galantamine will be increased up to 24 mg (if tolerable).

Treatment:

Drug: Galantamine