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

Phase 2

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: Donepezil; Drug: AZD3480

• Registration Number: NCT00501111
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-12
• Study First Submitted QC: 2007-07-12
• Study First Posted: 2007-07-13
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-22
• Last Update Posted: 2014-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 659

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Donepezil	donepezil
3	AZD3480	AZD3480

Primary Outcome Measures

Name	Time	Method
Change in ADAS-Cog	assessed after 12 weeks treatment

Secondary Outcome Measures

Name	Time	Method
Change in ADCS-CGIC, Computerized neurological test battery (CDR) and MMSE	assessed after 12 weeks treatment

Trial Locations

Locations (1)

Research Site; 🇬🇧 Swindon, United Kingdom