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

NCT ID: NCT00501111

Last Updated: 2014-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

659 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-08-31

Brief Summary

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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

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

2

donepezil

Group Type ACTIVE_COMPARATOR

Donepezil

Intervention Type DRUG

3

AZD3480

Group Type EXPERIMENTAL

AZD3480

Intervention Type DRUG

3 oral doses

Interventions

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AZD3480

3 oral doses

Intervention Type DRUG

Donepezil

Intervention Type DRUG

Other Intervention Names

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Aricept

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca AZD3480, Medical Science Director

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Graz, Osterreich, Austria

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Innsbruck, Osterreich, Austria

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Vienna, Osterreich, Austria

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Linz, , Austria

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Aalst, Belgium, Belgium

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Antwerp, Belgium, Belgium

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Hasselt, Belgium, Belgium

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Leuven, Belgium, Belgium

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Sint-Truiden, Belgium, Belgium

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Ottawa, Ontario, Canada

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Peterborough, Ontario, Canada

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Toronto, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Québec, Quebec, Canada

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Verdun, Quebec, Canada

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Regina, Saskatchewan, Canada

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Brno, , Czechia

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Havlíčkův Brod, , Czechia

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Hradec Králové, , Czechia

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Kladno, , Czechia

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Litoměřice, , Czechia

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Nový Jičín, , Czechia

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Olomouc, , Czechia

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Ostrava - Poruba, , Czechia

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Prague, , Czechia

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Prostějov, , Czechia

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Bad Saarow, , Germany

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Berlin, , Germany

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Dresden, , Germany

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Freiburg im Breisgau, , Germany

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Heidelberg, , Germany

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Kiel-kronshagen, , Germany

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Leipzig, , Germany

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Lübeck, , Germany

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Magdeburg, , Germany

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Mannheim, , Germany

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München, , Germany

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Nuremberg, , Germany

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Piteşti, Argeş, Romania

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Târgu Mureş, Mureș County, Romania

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Bucharest, , Romania

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Iași, , Romania

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Sibiu, , Romania

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Moscow, , Russia

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Saint Petersburg, , Russia

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Smolensk, , Russia

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Palma de Mallorca, Balearic Islands, Spain

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Salamanca, Castille and León, Spain

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Barcelona, Catalonia, Spain

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Hospitalet de Llobregat(barcel, Catalonia, Spain

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Salt (girona), Catalonia, Spain

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Terrassa, Catalonia, Spain

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Madrid, Madrid, Spain

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Castellon, Valencia, Spain

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Baracaldo (vizcaya), , Spain

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Uckfield, E Sussex, United Kingdom

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Southampton, Hampshire, United Kingdom

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Blackpool, Lancashire, United Kingdom

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Bradford, , United Kingdom

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London, , United Kingdom

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Peterborough, , United Kingdom

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Swindon, , United Kingdom

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Countries

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Austria Belgium Bulgaria Canada Czechia Germany Romania Russia Spain United Kingdom

Related Links

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Other Identifiers

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EuDract 2007-00835-24

Identifier Type: -

Identifier Source: secondary_id

D3690C00010

Identifier Type: -

Identifier Source: org_study_id

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