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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

NCT ID: NCT01734395

Last Updated: 2013-08-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1882 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-01-31

Brief Summary

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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

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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

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Alzheimer's Disease

Keywords

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Alzheimer's disease Caregiver's Burden in Alzheimer's disease Galantamine Razadyne Reminyl

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Galantamine

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).

Galantamine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Razadyne Reminyl

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Korea, Ltd., Korea Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd., Korea

Other Identifiers

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GAL-KOR-024

Identifier Type: OTHER

Identifier Source: secondary_id

GALALZ4045

Identifier Type: OTHER

Identifier Source: secondary_id

CR100958

Identifier Type: -

Identifier Source: org_study_id