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

July 22, 2014 updated by: AstraZeneca

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

659

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria
        • Research Site
    • Osterreich
      • Graz, Osterreich, Austria
        • Research Site
      • Innsbruck, Osterreich, Austria
        • Research Site
      • Wien, Osterreich, Austria
        • Research Site
  • Belgium
      • Aalst, Belgium
        • Research Site
      • Antwerpen, Belgium
        • Research Site
      • Hasselt, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
      • Sint-truiden, Belgium
        • Research Site
  • Bulgaria
      • Pleven, Bulgaria
        • Research Site
      • Plovdiv, Bulgaria
        • Research Site
      • Ruse, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Edmonton, Alberta, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • Ontario
      • Ottawa, Ontario, Canada
        • Research Site
      • Peterborough, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Greenfield Park, Quebec, Canada
        • Research Site
      • Verdun, Quebec, Canada
        • Research Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Havlickuv Brod, Czech Republic
        • Research Site
      • Hradec Kralove, Czech Republic
        • Research Site
      • Kladno, Czech Republic
        • Research Site
      • Litomerice, Czech Republic
        • Research Site
      • Novy Jicin, Czech Republic
        • Research Site
      • Olomouc, Czech Republic
        • Research Site
      • Ostrava - Poruba, Czech Republic
        • Research Site
      • Praha 2, Czech Republic
        • Research Site
      • Prostejov, Czech Republic
        • Research Site
  • Germany
      • Bad Saarow, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Freiburg, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Kiel-kronshagen, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Lubeck, Germany
        • Research Site
      • Magdeburg, Germany
        • Research Site
      • Mannheim, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Nurnberg, Germany
        • Research Site
  • Romania
      • Bucharest, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
      • Sibiu, Romania
        • Research Site
    • Arges
      • Pitesti, Arges, Romania
        • Research Site
    • Mures
      • Targu Mures, Mures, Romania
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • Saint-petersburg, Russian Federation
        • Research Site
      • Smolensk, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
  • Spain
      • Baracaldo (vizcaya), Spain
        • Research Site
    • Castilla Leon
      • Salamanca, Castilla Leon, Spain
        • Research Site
    • Cataluna
      • Barcelona, Cataluna, Spain
        • Research Site
      • Hospitalet de Llobregat(barcel, Cataluna, Spain
        • Research Site
      • Salt (girona), Cataluna, Spain
        • Research Site
      • Terrassa, Cataluna, Spain
        • Research Site
    • Comunidad Valenciana
      • Castellon, Comunidad Valenciana, Spain
        • Research Site
    • Comunidad de Madrid
      • Madrid, Comunidad de Madrid, Spain
        • Research Site
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain
        • Research Site
  • United Kingdom
      • Bradford, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Peterborough, United Kingdom
        • Research Site
      • Swindon, United Kingdom
        • Research Site
    • E Sussex
      • Uckfield, E Sussex, United Kingdom
        • Research Site
    • Hampshire
      • Southampton, Hampshire, United Kingdom
        • Research Site
    • Lancashire
      • Blackpool, Lancashire, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Placebo
Active Comparator: 2
donepezil
Drug: Donepezil
Other Names:
  • Aricept
Experimental: 3
AZD3480
Drug: AZD3480
3 oral doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in ADAS-Cog
Time Frame: assessed after 12 weeks treatment
assessed after 12 weeks treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in ADCS-CGIC, Computerized neurological test battery (CDR) and MMSE
Time Frame: assessed after 12 weeks treatment
assessed after 12 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca AZD3480, Medical Science Director, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

July 12, 2007

First Submitted That Met QC Criteria

July 12, 2007

First Posted (Estimate)

July 13, 2007

Study Record Updates

Last Update Posted (Estimate)

July 23, 2014

Last Update Submitted That Met QC Criteria

July 22, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3690C00010
  • EuDract 2007-00835-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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