SB-742457 And Donepezil In Alzheimer's Disease

NCT ID: NCT00348192

Last Updated: 2009-06-02

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

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

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

donepezil

Intervention Type DRUG

Other Intervention Names

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SB-742457

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 Alzheimers 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 or donepezil.
* Subjects with conditions which might be exacerbated by exposure to donepezil.
* 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

Site Status

GSK Investigational Site

Vienna, , Austria

Site Status

GSK Investigational Site

Vienna, , Austria

Site Status

GSK Investigational Site

Sofia, , Bulgaria

Site Status

GSK Investigational Site

Sofia, , Bulgaria

Site Status

GSK Investigational Site

Varna, , Bulgaria

Site Status

GSK Investigational Site

Valparaíso, Región de Valparaíso, Chile

Site Status

GSK Investigational Site

Providencia / Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Tallinn, , Estonia

Site Status

GSK Investigational Site

Tartu, , Estonia

Site Status

GSK Investigational Site

Ostfildern, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Hüttenberg, Hesse, Germany

Site Status

GSK Investigational Site

Achim, Lower Saxony, Germany

Site Status

GSK Investigational Site

Baesweiler, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Hattingen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Bratislava, , Slovakia

Site Status

GSK Investigational Site

Bratislava, , Slovakia

Site Status

GSK Investigational Site

Bratislava, , Slovakia

Site Status

GSK Investigational Site

Bradford, , United Kingdom

Site Status

GSK Investigational Site

Swindon, , United Kingdom

Site Status

GSK Investigational Site

West of Scotland Science Park, Glasgow, , United Kingdom

Site Status

Countries

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Austria Bulgaria Chile Estonia Germany Russia Slovakia United Kingdom

References

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Maher-Edwards G, Dixon R, Hunter J, Gold M, Hopton G, Jacobs G, Hunter J, Williams P. SB-742457 and donepezil in Alzheimer disease: a randomized, placebo-controlled study. Int J Geriatr Psychiatry. 2011 May;26(5):536-44. doi: 10.1002/gps.2562. Epub 2010 Sep 24.

Reference Type DERIVED
PMID: 20872778 (View on PubMed)

Other Identifiers

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AZ3106242

Identifier Type: -

Identifier Source: org_study_id

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