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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00501111
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE July 12, 2007
First Posted Date  ICMJE July 13, 2007
Last Update Posted Date July 23, 2014
Study Start Date  ICMJE July 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2007)
Change in ADAS-Cog [ Time Frame: assessed after 12 weeks treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2007)
Change in ADAS-Cog after 12 weeks treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2007)
Change in ADCS-CGIC, Computerized neurological test battery (CDR) and MMSE [ Time Frame: assessed after 12 weeks treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2007)
Change in ADCS-CGIC, Computerized neurological test battery (CDR) and MMSE after 12 weeks treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: AZD3480
    3 oral doses
  • Drug: Donepezil
    Other Name: Aricept
Study Arms  ICMJE
  • No Intervention: 1
    Placebo
  • Active Comparator: 2
    donepezil
    Intervention: Drug: Donepezil
  • Experimental: 3
    AZD3480
    Intervention: Drug: AZD3480
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2008)
659
Original Estimated Enrollment  ICMJE
 (submitted: July 12, 2007)
525
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Bulgaria,   Canada,   Czech Republic,   Germany,   Romania,   Russian Federation,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00501111
Other Study ID Numbers  ICMJE D3690C00010
EuDract 2007-00835-24
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AstraZeneca AZD3480, Medical Science Director AstraZeneca
PRS Account AstraZeneca
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP