A Multi-centre, Double-blind, Double-dummy, Placebo Controlled Parallel Group Randomized Phase IIb Proof of Concept Study With 3 Oral Dose Groups of AZD3480 or Donepezil During 12 Weeks Treatment in Patients With Alzheimer's Disease

AstraZeneca1 site in 1 country659 target enrollmentJuly 2007

ConditionsAlzheimer Disease

InterventionsDonepezil AZD3480

DrugsAZD3480 Donepezil

Overview

Phase: Phase 2
Intervention: Donepezil
Conditions: Alzheimer Disease
Sponsor: AstraZeneca
Enrollment: 659
Locations: 1
Primary Endpoint: Change in ADAS-Cog
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2007

End Date

August 2008

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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