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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: donepezil 5-10mg; Drug: SB-742457 15mg; Drug: Placebo; Drug: SB-742457 35mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00710684

AZ3110866

Details and patient eligibility

About

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.

Enrollment: 682 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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682 participants in 3 patient groups, including a placebo group

DONEPEZIL + SB-742457 15 MG

Experimental group

Description:

SB-742457 - 15mg added to existing donepezil treatment

Treatment:

Drug: SB-742457 15mg

Drug: donepezil 5-10mg

DONEPEZIL + PLACEBO

Placebo Comparator group

Description:

Placebo added to existing donepezil

Treatment:

Drug: Placebo

Drug: donepezil 5-10mg

DONEPEZIL + SB-742457 35 MG

Experimental group

Description:

SB-742457 - 35mg added to existing donepezil

Treatment:

Drug: SB-742457 35mg

Drug: donepezil 5-10mg