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A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease | Clinical Trials | Clareo Health

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A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease

Study AZ3110866, a Fixed Dose Study of SB-742457 Versus Placebo When Added to Existing Donepezil Treatment in Subjects With Mild-to-moderate Alzheimer's Disease

NCT00710684•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The study is designed to investigate the safety and efficacy of SB-742457 when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.

Eligibility

Age

50 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects and their caregivers must provide informed consent prior to study entry.
•Subjects must have a clinical diagnosis of probable mild-to-moderate Alzheimer's disease with no evidence of disorders that are thought to be the cause of, or contributing to the severity of the subject's dementia and a documented history of at least 6 months of ongoing donepezil therapy with stable dosing for at least the last 2 months.
•Subjects must have a regular caregiver who is willing to attend visits, oversee the subject's compliance with the study and report on the subject's status.
•Female subjects of child-bearing potential must agree to abstinence or an approved form of birth control.
•Subjects must have adequate blood pressure and laboratory values.

Exclusion Criteria

•Subjects with a diagnosis of possible, probable or definite vascular dementia may not participate.
•Subjects with known hypersensitivity to sunlight or a history of seizures, previous exposure to SB-742457, taking agents for which there is a theoretical risk of interaction with SB-742457, or taking medication for Alzheimer's disease or centrally acting agents which might impact study outcomes may not participate.

Locations (102)

GSK Investigational Site

Litchfield Park, Arizona, United States

GSK Investigational Site

Fresno, California, United States

GSK Investigational Site

Rancho Mirage, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Hallandale, Florida, United States

GSK Investigational Site

Hialeah, Florida, United States

GSK Investigational Site

Paterson, New Jersey, United States

GSK Investigational Site

Syracuse, New York, United States

GSK Investigational Site

Winston-Salem, North Carolina, United States

GSK Investigational Site

Columbus, Ohio, United States

Key Dates

Start Date

July 1, 2008

Primary Completion Date

May 21, 2010

Completion Date

November 16, 2010

Last Updated

December 7, 2017

Enrollment

682

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

SB-742457 15mg

DRUG

SB-742457 35mg

DRUG

Placebo

DRUG

donepezil 5-10mg

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 7, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

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