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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mild to Moderate Alzheimer's Disease Drug: AZD1446 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
AZD1446 60mg once daily + donepezil 10mg
 Drug: AZD1446
capsules, oral, 3 times daily
Experimental: 2
AZD1446 60mg three times daily + donepezil 10mg
 Drug: AZD1446
capsules, oral, 3 times daily
Experimental: 3
AZD1446 30mg three times daily + donepezil 10mg
 Drug: AZD1446
capsules, oral, 3 times daily
Placebo Comparator: 4
placebo + donepezil 10mg
 Drug: Placebo
capsules, oral, 3 times daily, 4 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039701


Locations
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Czech Republic
Research Site
Litomerice, Czech Republic
Research Site
Praha 10 - Strasnice, Czech Republic
Research Site
Praha 10, Czech Republic
Research Site
Praha 6, Czech Republic
Hungary
Research Site
Debrecen, Hungary
Research Site
Esztergom, Hungary
Research Site
Miskolc, Hungary
Research Site
Nagykallo, Hungary
Research Site
Nyiregyhaza, Hungary
Research Site
Szeged, Hungary
Slovakia
Research Site
Bratislava, Slovakia
Research Site
Roznava, Slovakia
Research Site
Zlate Moravce, Slovakia
Sponsors and Collaborators
AstraZeneca
More Information
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Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01039701    
Other Study ID Numbers: D1950C00006
First Posted: December 25, 2009    Key Record Dates
Last Update Posted: August 11, 2010
Last Verified: August 2010
Keywords provided by AstraZeneca:
safety
tolerability
mild to moderate Alzheimer's disease
To determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil in patients with mild to moderate Alzheimer's disease
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders