Clinical trial NCT00501111: Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's Disease
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: Dementia
Alzheimer Type
Alzheimer Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-07-13
Enrollment: 659
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in ADAS-Cog
timeFrame: assessed after 12 weeks treatment
Secondary outcomes:
measure: Change in ADCS-CGIC, Computerized neurological test battery (CDR) and MMSE
timeFrame: assessed after 12 weeks treatment
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Research Site
state: Osterreich
city: Innsbruck
country: Austria
facility: Research Site
state: Osterreich
city: Wien
country: Austria
facility: Research Site
state: Osterreich
city: Linz
country: Austria
facility: Research Site
city: Aalst
country: Belgium
facility: Research Site
city: Antwerpen
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Sint-truiden
country: Belgium
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Ruse
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Peterborough
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Research Site
state: Quebec
city: Verdun
country: Canada
facility: Research Site
state: Quebec
city: Regina
country: Canada
facility: Research Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Havlickuv Brod
country: Czech Republic
facility: Research Site
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Kladno
country: Czech Republic
facility: Research Site
city: Litomerice
country: Czech Republic
facility: Research Site
city: Novy Jicin
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Ostrava - Poruba
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
facility: Research Site
city: Prostejov
country: Czech Republic
facility: Research Site
city: Bad Saarow
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Kiel-kronshagen
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Lubeck
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Nurnberg
country: Germany
facility: Research Site
city: Pitesti
country: Romania
facility: Research Site
state: Arges
city: Targu Mures
country: Romania
facility: Research Site
state: Mures
city: Bucharest
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Sibiu
country: Romania
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint-petersburg
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
state: Castilla Leon
city: Barcelona
country: Spain
facility: Research Site
state: Cataluna
city: Hospitalet de Llobregat(barcel
country: Spain
facility: Research Site
state: Cataluna
city: Salt (girona)
country: Spain
facility: Research Site
state: Cataluna
city: Terrassa
country: Spain
facility: Research Site
state: Cataluna
city: Madrid
country: Spain
facility: Research Site
state: Comunidad de Madrid
city: Castellon
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Islas Baleares
city: Baracaldo (vizcaya)
country: Spain
facility: Research Site
city: Uckfield
country: United Kingdom
facility: Research Site
state: E Sussex
city: Southampton
country: United Kingdom
facility: Research Site
state: Hampshire
city: Blackpool
country: United Kingdom
facility: Research Site
state: Lancashire
city: Bradford
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Peterborough
country: United Kingdom
facility: Research Site
city: Swindon
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AZD3480, Medical Science Director
role: STUDY_DIRECTOR
References: