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4 Week, Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease (ROBIN)

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: NCT01039701
Recruitment Status : Completed
First Posted : December 25, 2009
Last Update Posted : August 11, 2010
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE December 20, 2009
First Posted Date  ICMJE December 25, 2009
Last Update Posted Date August 11, 2010
Study Start Date  ICMJE December 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2009)		 Nature and incidence of adverse events [ Time Frame: From the enrollment visit until the last study follow-up visit. The measure will be taken at each scheduled study visit and in between visits , if any adverse events occur. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2009)
  • To evaluate any effects PK of AZD1446 as an add-on treatment to donepezil on the PK of donepezil [ Time Frame: Twice during the study: at Visit 2 and Visit 10. ]
  • To characterize the PK of AZD1446 as an add-on treatment to donepezil in AD patients [ Time Frame: Twice during the study: at Visit 8 and Visit 10. ]
  • To explore the effects of 3 dose regimens of AZD1446 compared to placebo as an add-on treatment to donepezil on changes in global functioning using ADCS-CGIC [ Time Frame: Baseline assessment at Visit 2 and a follow-up assessment at Visit 10 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 4 Week, Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease
Official Title  ICMJE Safety, Tolerability and Pharmacokinetics of 3 Dose Regimens of AZD1446 vs. Placebo as an Add-on Treatment to Donepezil: A Multi-centre, Double-blind, Randomised, Placebo Controlled, Parallel Group Phase IIa Study in Patients With Mild to Moderate Alzheimer's Disease During 4 Weeks of Treatment
Brief Summary The primary purpose of the study is to determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil for 4 weeks in patients with mild to moderate Alzheimer's disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Mild to Moderate Alzheimer's Disease
Intervention  ICMJE
  • Drug: AZD1446
    capsules, oral, 3 times daily
  • Drug: Placebo
    capsules, oral, 3 times daily, 4 weeks
Study Arms  ICMJE
  • Experimental: 1
    AZD1446 60mg once daily + donepezil 10mg
    Intervention: Drug: AZD1446
  • Experimental: 2
    AZD1446 60mg three times daily + donepezil 10mg
    Intervention: Drug: AZD1446
  • Experimental: 3
    AZD1446 30mg three times daily + donepezil 10mg
    Intervention: Drug: AZD1446
  • Placebo Comparator: 4
    placebo + donepezil 10mg
    Intervention: Drug: Placebo
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: June 29, 2010)		 99
Original Estimated Enrollment  ICMJE
 (submitted: December 24, 2009)		 54
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • history of progressive worsening of memory and other cognitive functions for at least 12 months
  • treatment with stable dose of donepezil (10 mg) for at least 3 months
  • the patient should have an appropriate caregiver, who is required for all study visits

Exclusion Criteria:

  • history of allergy/hypersensitivity reactions
  • significant neurological disease or dementia other than Alzheimer's disease
  • myocardial infarction or acute coronary syndrome within the last year
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 Czech Republic,   Hungary,   Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01039701
Other Study ID Numbers  ICMJE D1950C00006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party MSD, AstraZeneca
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AstraZeneca
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date August 2010

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