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

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD3480
Donepezil
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Dementia, Alzheimer Type, Alzheimer Disease

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

1

2

3

Arm Description

Placebo

donepezil

AZD3480

Outcomes

Primary Outcome Measures

Change in ADAS-Cog

Secondary Outcome Measures

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

Full Information

First Posted
July 12, 2007
Last Updated
July 22, 2014
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00501111
Brief Title
Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's Disease
Acronym
Sirocco
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Dementia, Alzheimer Type, Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
659 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Placebo
Arm Title
2
Arm Type
Active Comparator
Arm Description
donepezil
Arm Title
3
Arm Type
Experimental
Arm Description
AZD3480
Intervention Type
Drug
Intervention Name(s)
AZD3480
Intervention Description
3 oral doses
Intervention Type
Drug
Intervention Name(s)
Donepezil
Other Intervention Name(s)
Aricept
Primary Outcome Measure Information:
Title
Change in ADAS-Cog
Time Frame
assessed after 12 weeks treatment
Secondary Outcome Measure Information:
Title
Change in ADCS-CGIC, Computerized neurological test battery (CDR) and MMSE
Time Frame
assessed after 12 weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AZD3480, Medical Science Director
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Graz
State/Province
Osterreich
Country
Austria
Facility Name
Research Site
City
Innsbruck
State/Province
Osterreich
Country
Austria
Facility Name
Research Site
City
Wien
State/Province
Osterreich
Country
Austria
Facility Name
Research Site
City
Linz
Country
Austria
Facility Name
Research Site
City
Aalst
Country
Belgium
Facility Name
Research Site
City
Antwerpen
Country
Belgium
Facility Name
Research Site
City
Hasselt
Country
Belgium
Facility Name
Research Site
City
Leuven
Country
Belgium
Facility Name
Research Site
City
Sint-truiden
Country
Belgium
Facility Name
Research Site
City
Pleven
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
Country
Bulgaria
Facility Name
Research Site
City
Ruse
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Varna
Country
Bulgaria
Facility Name
Research Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Peterborough
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Greenfield Park
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Verdun
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Regina
State/Province
Saskatchewan
Country
Canada
Facility Name
Research Site
City
Quebec
Country
Canada
Facility Name
Research Site
City
Brno
Country
Czech Republic
Facility Name
Research Site
City
Havlickuv Brod
Country
Czech Republic
Facility Name
Research Site
City
Hradec Kralove
Country
Czech Republic
Facility Name
Research Site
City
Kladno
Country
Czech Republic
Facility Name
Research Site
City
Litomerice
Country
Czech Republic
Facility Name
Research Site
City
Novy Jicin
Country
Czech Republic
Facility Name
Research Site
City
Olomouc
Country
Czech Republic
Facility Name
Research Site
City
Ostrava - Poruba
Country
Czech Republic
Facility Name
Research Site
City
Praha 2
Country
Czech Republic
Facility Name
Research Site
City
Prostejov
Country
Czech Republic
Facility Name
Research Site
City
Bad Saarow
Country
Germany
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Dresden
Country
Germany
Facility Name
Research Site
City
Freiburg
Country
Germany
Facility Name
Research Site
City
Heidelberg
Country
Germany
Facility Name
Research Site
City
Kiel-kronshagen
Country
Germany
Facility Name
Research Site
City
Leipzig
Country
Germany
Facility Name
Research Site
City
Lubeck
Country
Germany
Facility Name
Research Site
City
Magdeburg
Country
Germany
Facility Name
Research Site
City
Mannheim
Country
Germany
Facility Name
Research Site
City
Munchen
Country
Germany
Facility Name
Research Site
City
Nurnberg
Country
Germany
Facility Name
Research Site
City
Pitesti
State/Province
Arges
Country
Romania
Facility Name
Research Site
City
Targu Mures
State/Province
Mures
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Iasi
Country
Romania
Facility Name
Research Site
City
Sibiu
Country
Romania
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Saint-petersburg
Country
Russian Federation
Facility Name
Research Site
City
Smolensk
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Salamanca
State/Province
Castilla Leon
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluna
Country
Spain
Facility Name
Research Site
City
Hospitalet de Llobregat(barcel
State/Province
Cataluna
Country
Spain
Facility Name
Research Site
City
Salt (girona)
State/Province
Cataluna
Country
Spain
Facility Name
Research Site
City
Terrassa
State/Province
Cataluna
Country
Spain
Facility Name
Research Site
City
Madrid
State/Province
Comunidad de Madrid
Country
Spain
Facility Name
Research Site
City
Castellon
State/Province
Comunidad Valenciana
Country
Spain
Facility Name
Research Site
City
Palma de Mallorca
State/Province
Islas Baleares
Country
Spain
Facility Name
Research Site
City
Baracaldo (vizcaya)
Country
Spain
Facility Name
Research Site
City
Uckfield
State/Province
E Sussex
Country
United Kingdom
Facility Name
Research Site
City
Southampton
State/Province
Hampshire
Country
United Kingdom
Facility Name
Research Site
City
Blackpool
State/Province
Lancashire
Country
United Kingdom
Facility Name
Research Site
City
Bradford
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Peterborough
Country
United Kingdom
Facility Name
Research Site
City
Swindon
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=210&filename=D3690C00010.pdf
Description
D3690C00010 Clinical Stusy Report Synopsis

Learn more about this trial

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

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