Alzheimer Disease Clinical Trial
— SiroccoOfficial 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
| Verified date | July 2014 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 659 |
| Est. completion date | August 2008 |
| Est. primary completion date | August 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years to 85 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Research Site | Graz | Osterreich |
| Austria | Research Site | Innsbruck | Osterreich |
| Austria | Research Site | Linz | |
| Austria | Research Site | Wien | Osterreich |
| Belgium | Research Site | Aalst | |
| Belgium | Research Site | Antwerpen | |
| Belgium | Research Site | Hasselt | |
| Belgium | Research Site | Leuven | |
| Belgium | Research Site | Sint-truiden | |
| Bulgaria | Research Site | Pleven | |
| Bulgaria | Research Site | Plovdiv | |
| Bulgaria | Research Site | Ruse | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Varna | |
| Canada | Research Site | Calgary | Alberta |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Greenfield Park | Quebec |
| Canada | Research Site | Ottawa | Ontario |
| Canada | Research Site | Peterborough | Ontario |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Regina | Saskatchewan |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Verdun | Quebec |
| Canada | Research Site | Winnipeg | Manitoba |
| Czech Republic | Research Site | 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 | |
| Germany | Research Site | 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 | |
| Romania | Research Site | Bucharest | |
| Romania | Research Site | Iasi | |
| Romania | Research Site | Pitesti | Arges |
| Romania | Research Site | Sibiu | |
| Romania | Research Site | Targu Mures | Mures |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Saint-petersburg | |
| Russian Federation | Research Site | Smolensk | |
| Russian Federation | Research Site | St. Petersburg | |
| Spain | Research Site | Baracaldo (vizcaya) | |
| Spain | Research Site | Barcelona | Cataluna |
| Spain | Research Site | Castellon | Comunidad Valenciana |
| Spain | Research Site | Hospitalet de Llobregat(barcel | Cataluna |
| Spain | Research Site | Madrid | Comunidad de Madrid |
| Spain | Research Site | Palma de Mallorca | Islas Baleares |
| Spain | Research Site | Salamanca | Castilla Leon |
| Spain | Research Site | Salt (girona) | Cataluna |
| Spain | Research Site | Terrassa | Cataluna |
| United Kingdom | Research Site | Blackpool | Lancashire |
| United Kingdom | Research Site | Bradford | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | Peterborough | |
| United Kingdom | Research Site | Southampton | Hampshire |
| United Kingdom | Research Site | Swindon | |
| United Kingdom | Research Site | Uckfield | E Sussex |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Austria, Belgium, Bulgaria, Canada, Czech Republic, Germany, Romania, Russian Federation, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in ADAS-Cog | assessed after 12 weeks treatment | ||
| Secondary | Change in ADCS-CGIC, Computerized neurological test battery (CDR) and MMSE | assessed after 12 weeks treatment |
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