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

August 10, 2010 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Litomerice, Czech Republic
        • Research Site
      • Praha 10, Czech Republic
        • Research Site
      • Praha 10 - Strasnice, Czech Republic
        • Research Site
      • Praha 6, Czech Republic
        • Research Site
  • Hungary
      • Debrecen, Hungary
        • Research Site
      • Esztergom, Hungary
        • Research Site
      • Miskolc, Hungary
        • Research Site
      • Nagykallo, Hungary
        • Research Site
      • Nyiregyhaza, Hungary
        • Research Site
      • Szeged, Hungary
        • Research Site
  • Slovakia
      • Bratislava, Slovakia
        • Research Site
      • Roznava, Slovakia
        • Research Site
      • Zlate Moravce, Slovakia
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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

Outcome Measure
Time Frame
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.
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.
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
Baseline assessment at Visit 2 and a follow-up assessment at Visit 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

December 20, 2009

First Submitted That Met QC Criteria

December 24, 2009

First Posted (Estimate)

December 25, 2009

Study Record Updates

Last Update Posted (Estimate)

August 11, 2010

Last Update Submitted That Met QC Criteria

August 10, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1950C00006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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