A Dose Ranging Study To Investigate The Efficacy And Safety Of SB-742457 In Alzheimer's Disease

NCT ID: NCT00224497

Last Updated: 2009-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Brief Summary

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The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it has on the symptoms of mild to moderate Alzheimer's disease. SB-742457 is a new treatment which is thought to increase the levels of certain chemicals in the brain that are often decreased in patients with Alzheimer's disease.

Detailed Description

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Conditions

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Alzheimer's Disease

Keywords

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Alzheimer's disease cognition global functioning symptomatic B-742457

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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SB-742457

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of probable mild-to-moderate Alzheimer's disease as determined by the NINCDS-ADRDA and DSM-IV criteria with an MMSE score of 12-24.
* Subjects and their caregivers must provide informed consent prior to study entry.
* Adequate blood pressure and laboratory values.

Exclusion Criteria

* Females of child-bearing potential.
* Have other causes of dementia such as vascular damage, depression, bipolar affective disorder, schizophrenia, syphilis, vitamin B12 deficiency or thyroid deficiency.
* Subjects taking medication for Alzheimer's disease or centrally acting agents which might impact study outcomes.
* Subjects taking agents for which there is a theoretical risk of interaction with SB-742457.
* Subjects with known hypersensitivity to sunlight or seizures.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Hall in Tirol, , Austria

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GSK Investigational Site

Innsbruck, , Austria

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GSK Investigational Site

Retz, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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GSK Investigational Site

Valparaíso, Región de Valparaíso, Chile

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GSK Investigational Site

Providencia / Santiago, Región Metro de Santiago, Chile

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Santiago, Región Metro de Santiago, Chile

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GSK Investigational Site

Split, , Croatia

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Zagreb, , Croatia

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Olomouc, , Czechia

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Ostrava, , Czechia

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Prague, , Czechia

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Rychnov nad Kněžnou, , Czechia

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Athens, , Greece

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Athens, , Greece

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Melíssia, , Greece

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Thessaloniki, , Greece

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Auckland, , New Zealand

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Christchurch, , New Zealand

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Mosina, , Poland

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Olsztyn, , Poland

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Warsaw, , Poland

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Rimavská Sobota, , Slovakia

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Oakdale, , South Africa

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Rosebank, , South Africa

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Somerset West, , South Africa

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Seoul, , South Korea

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Seoul, , South Korea

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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GSK Investigational Site

Sant Cugat Del Vallés/, , Spain

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GSK Investigational Site

Tarrasa, Barcelona, , Spain

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Countries

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Brazil Austria Bulgaria Chile Croatia Czechia Greece New Zealand Poland Russia Slovakia South Africa South Korea Spain

Other Identifiers

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AZ3100603

Identifier Type: -

Identifier Source: org_study_id