Back to results4 Week, Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease (ROBIN)
Primary Purpose
Mild to Moderate Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD1446
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mild to Moderate Alzheimer's Disease focused on measuring 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
Eligibility 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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
AZD1446 60mg once daily + donepezil 10mg
AZD1446 60mg three times daily + donepezil 10mg
AZD1446 30mg three times daily + donepezil 10mg
placebo + donepezil 10mg
Outcomes
Primary Outcome Measures
Nature and incidence of adverse events
Secondary Outcome Measures
To evaluate any effects PK of AZD1446 as an add-on treatment to donepezil on the PK of donepezil
To characterize the PK of AZD1446 as an add-on treatment to donepezil in AD patients
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01039701
Brief Title
4 Week, Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease
Acronym
ROBIN
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 Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Alzheimer's Disease
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AZD1446 60mg once daily + donepezil 10mg
Arm Title
2
Arm Type
Experimental
Arm Description
AZD1446 60mg three times daily + donepezil 10mg
Arm Title
3
Arm Type
Experimental
Arm Description
AZD1446 30mg three times daily + donepezil 10mg
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
placebo + donepezil 10mg
Intervention Type
Drug
Intervention Name(s)
AZD1446
Intervention Description
capsules, oral, 3 times daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
capsules, oral, 3 times daily, 4 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
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.
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Research Site
City
Litomerice
Country
Czech Republic
Facility Name
Research Site
City
Praha 10 - Strasnice
Country
Czech Republic
Facility Name
Research Site
City
Praha 10
Country
Czech Republic
Facility Name
Research Site
City
Praha 6
Country
Czech Republic
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Esztergom
Country
Hungary
Facility Name
Research Site
City
Miskolc
Country
Hungary
Facility Name
Research Site
City
Nagykallo
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
Country
Hungary
Facility Name
Research Site
City
Szeged
Country
Hungary
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Roznava
Country
Slovakia
Facility Name
Research Site
City
Zlate Moravce
Country
Slovakia
12. IPD Sharing Statement
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4 Week, Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease
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