Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's Disease
Sirocco
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
2 other identifiers
interventional
659
10 countries
70
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 alzheimer-disease
Started Jul 2007
Shorter than P25 for phase_2 alzheimer-disease
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 12, 2007
CompletedFirst Posted
Study publicly available on registry
July 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedJuly 23, 2014
July 1, 2014
1.1 years
July 12, 2007
July 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in ADAS-Cog
assessed after 12 weeks treatment
Secondary Outcomes (1)
Change in ADCS-CGIC, Computerized neurological test battery (CDR) and MMSE
assessed after 12 weeks treatment
Study Arms (3)
1
NO INTERVENTIONPlacebo
2
ACTIVE COMPARATORdonepezil
3
EXPERIMENTALAZD3480
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (70)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca AZD3480, Medical Science Director
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2007
First Posted
July 13, 2007
Study Start
July 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
July 23, 2014
Record last verified: 2014-07