The Efficacy of Galantamine Treatment on Attention in Patients With

Status Completed

Clinical Trial Summary

This study will examine whether the administration of galantamine is effective for improvement of attention and more effective for patients with serious disturbance of attention by administering galantamine to patients with Alzheimer's dementia and performing an attention test on baseline, week 4 and 12.

Clinical Trial Description

This is an open label (all people know the identity of the intervention), multi-center, prospective study investigating the effect of galantamine on the attention of Alzheimer's dementia patients. The objectives of this study include the evaluation of the relationship between change in attention after 4 weeks of galantamine administration and to investigate the effect of study drug after 12 weeks administration (the difference in the improvement of attention after the administration of galantamine). The secondary objective of this study is to clarify the causal relationship between improvement of attention and activities of daily living (ADL). The design of this study is prospective, open-label, multi-center study. Study populations are probable Alzheimer's dementia patients diagnosed by NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's disease and Related Disorders Association), DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria. The efficacy of study drug will be assessed by evaluating cognitive function, attention and behavioral symptoms before and after the treatment using the following assessment tools: ADAS-K-cog11 (Alzheimer's Disease Assessment Scale - cognitive subscale), computerized attention test and activities of daily living. Safety evaluations include adverse event monitoring and clinical lab tests. The patient is administered oral galantamine 8 mg/day for the first 4 weeks and then 16 mg/day. The dose of galantamine is increased up to 24 mg if tolerated. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01054976
Study type	Interventional
Source	Janssen Korea, Ltd., Korea
Contact
Status	Completed
Phase	Phase 4
Start date	October 2006
Completion date	February 2009

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms