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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01039701
First received: December 20, 2009
Last updated: August 10, 2010
Last verified: August 2010
History of Changes
  Purpose

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 Intervention Phase
Mild to Moderate Alzheimer's Disease
 Drug: AZD1446
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: December 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039701

Locations
Czech Republic
Research Site
Litomerice, Czech Republic
Research Site
Praha 10, Czech Republic
Research Site
Praha 10 - Strasnice, 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

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01039701     History of Changes
Other Study ID Numbers: D1950C00006
Study First Received: December 20, 2009
Last Updated: August 10, 2010
Health Authority: Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Slovakia: State Institute for Drug Control

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:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
 Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013