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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00501111
First received: July 12, 2007
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
Drug: AZD3480
Drug: Donepezil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in ADAS-Cog [ Time Frame: assessed after 12 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in ADCS-CGIC, Computerized neurological test battery (CDR) and MMSE [ Time Frame: assessed after 12 weeks treatment ] [ Designated as safety issue: No ]

Enrollment: 659
Study Start Date: July 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Placebo
Active Comparator: 2
donepezil
Drug: Donepezil
Other Name: Aricept
Experimental: 3
AZD3480
Drug: AZD3480
3 oral doses

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501111

  Show 71 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AZD3480, Medical Science Director AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00501111     History of Changes
Other Study ID Numbers: D3690C00010, EuDract 2007-00835-24
Study First Received: July 12, 2007
Last Updated: July 22, 2014
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation

Keywords provided by AstraZeneca:
Dementia
Alzheimer Type
Alzheimer Disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014