Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's Disease (Sirocco)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00501111
First received: July 12, 2007
Last updated: September 25, 2008
Last verified: September 2008
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Purpose
The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with mild or moderate Alzheimer's disease, to assess the safety and tolerability of ZAD3480 and to define the optimal dose(s) to be used in future trials.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: AZD3480 Drug: Donepezil |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multi-Centre, Double-Blind, Double-Dummy, Placebo Controlled Parallel Group Randomized Phase IIb Proof of Concept Study With 3 Oral Dose Groups of AZD3480 or Donepezil During 12 Weeks Treatment in Patients With Alzheimer's Disease |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Change in ADAS-Cog [ Time Frame: assessed after 12 weeks treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in ADCS-CGIC, Computerized neurological test battery (CDR) and MMSE [ Time Frame: assessed after 12 weeks treatment ] [ Designated as safety issue: No ]
| Enrollment: | 659 |
| Study Start Date: | July 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Placebo
|
|
|
Active Comparator: 2
donepezil
|
Drug: Donepezil
Other Name: Aricept
|
|
Experimental: 3
AZD3480
|
Drug: AZD3480
3 oral doses
|
Eligibility| Ages Eligible for Study: | 60 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provision of informed consent from patient and caregiver
- Clinical prognosis of probable Alzheimer's disease
- Patient must have a caregiver visiting the patient at least three times weekly
Exclusion Criteria:
- Significant neurologic disease or dementia other than Alzheimer's disease
- Major depressive disorder, other major psychiatric disorder
- Use of acetylcholinesterase inhibitor or memantine for treatment of Alzheimer's disease within 8 weeks prior to enrollment
- Impaired vision and/or hearing making cognitive testing difficult
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501111
Show 71 Study Locations
Show 71 Study LocationsSponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca AZD3480, Medical Science Director | AstraZeneca |
More Information
Additional Information:
No publications provided
| Responsible Party: | Hans-Goran Hardemark - Medical Science Director, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00501111 History of Changes |
| Other Study ID Numbers: | D3690C00010, EuDract 2007-00835-24 |
| Study First Received: | July 12, 2007 |
| Last Updated: | September 25, 2008 |
| Health Authority: | Austria: Agency for Health and Food Safety Belgium: Federal Agency for Medicinal Products and Health Products Bulgaria: Bulgarian Drug Agency Canada: Health Canada Czech Republic: State Institute for Drug Control Germany: Federal Institute for Drugs and Medical Devices Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency Romania: National Medicines Agency Russia: Ministry of Health of the Russian Federation |
Keywords provided by AstraZeneca:
|
Dementia Alzheimer Type Alzheimer 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 June 17, 2013