Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's Disease (Sirocco)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: AZD3480; Drug: Donepezil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00501111

EuDract 2007-00835-24

D3690C00010

Details and patient eligibility

About

The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with mild or moderate Alzheimer's disease, to assess the safety and tolerability of ZAD3480 and to define the optimal dose(s) to be used in future trials.

Enrollment: 659 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of informed consent from patient and caregiver
• Clinical prognosis of probable Alzheimer's disease
• Patient must have a caregiver visiting the patient at least three times weekly

Exclusion criteria

• Significant neurologic disease or dementia other than Alzheimer's disease
• Major depressive disorder, other major psychiatric disorder
• Use of acetylcholinesterase inhibitor or memantine for treatment of Alzheimer's disease within 8 weeks prior to enrollment
• Impaired vision and/or hearing making cognitive testing difficult

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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659 participants in 3 patient groups

1

No Intervention group

Description:

Placebo

2

Active Comparator group

Description:

donepezil

Treatment:

Drug: Donepezil

3

Experimental group

Description:

AZD3480

Treatment:

Drug: AZD3480