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

AstraZeneca659 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

659

Conditions

Alzheimer Disease

Interventions

AZD3480DRUG

3 oral doses

DonepezilDRUG

Eligibility

Sex: ALLMin age: 60 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (70)

Outcomes

Primary Outcomes

Change in ADAS-Cog

Time frame: assessed after 12 weeks treatment

Secondary Outcomes

Change in ADCS-CGIC, Computerized neurological test battery (CDR) and MMSE

Time frame: assessed after 12 weeks treatment

Data from ClinicalTrials.gov

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Research Site

Graz, Osterreich, Austria

Research Site

Innsbruck, Osterreich, Austria

Research Site

Vienna, Osterreich, Austria

Research Site

Linz, Austria

Research Site

Aalst, Belgium, Belgium

Research Site

Antwerp, Belgium, Belgium

Research Site

Hasselt, Belgium, Belgium

Research Site

Leuven, Belgium, Belgium

Research Site

Sint-Truiden, Belgium, Belgium

Research Site

Pleven, Bulgaria

...and 60 more locations