NCT01734395

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,882 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Galantamine	This is an observational study. Galantamine 8 mg/day will be administered for the first 4 weeks and later on the dose will increased up to 24 mg (if tolerable). Galantamine dose will be adjusted according to the investigator's discretion.

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2012-11-27
• Last updated: 2013-08-05
• Results posted: 2013-08-05