Study of SB-742457 or Donepezil Versus Placebo in Subjects With Mild-to-moderate Alzheimer's Disease

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: Donepezil; Drug: Placebo; Drug: SB-742457

Study type: Interventional

Funder types: Industry

Identifiers

NCT00708552

AZ3110865

Details and patient eligibility

About

The study is designed to investigate the efficacy, safety and tolerability of SB-742457 versus placebo in subjects with mild-to-moderate Alzheimer's disease. SB-742457 is an experimental treatment which increases the levels of certain chemicals in the brain that are often decreased in patients with Alzheimer's disease.

Enrollment: 576 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 a documented 6-month history of AD symptoms
• 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 pregnancy testing and approved form of birth control.

Exclusion criteria

• Diagnosis of possible, probable or definite vascular dementia.
• History/evidence of any other CNS disorder that could be interpreted as a cause of dementia
• History of known or suspected seizures, loss of consciousness or significant head trauma
• Subjects with ECG, blood pressure and laboratory values outside of protocol criteria are excluded.
• Subjects with known photosensitivity
• Subjects with a history of 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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576 participants in 4 patient groups, including a placebo group

SB-742457 - 15mg

Experimental group

Description:

SB-742457 - 15mg

Treatment:

Drug: SB-742457

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

SB-742457 - 35mg

Experimental group

Description:

SB-742457 - 35mg

Treatment:

Drug: SB-742457

Donepezil

Active Comparator group

Treatment:

Drug: Donepezil