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Completed

NCT Number: NCT00501111

Proof of Concept Study of Cognitive Improvement 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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Graz, Osterreich, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD3480

Drug

3 oral doses

Donepezil

Drug

Other names: Aricept

Primary outcomes

  1. Change in ADAS-Cog

    Time frame: assessed after 12 weeks treatment

Secondary outcomes

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

    Time frame: assessed after 12 weeks treatment

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: Sirocco

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 13, 2007
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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