NCT00501111CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 659
- Locations
- 1
- Primary Endpoint
- Change in ADAS-Cog
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
2
Active Comparator
donepezil
Intervention: Donepezil (Drug)
3
Experimental
AZD3480
Intervention: AZD3480 (Drug)
Outcomes
Primary Outcomes
Change in ADAS-Cog
Time Frame: assessed after 12 weeks treatment
Secondary Outcomes
- Change in ADCS-CGIC, Computerized neurological test battery (CDR) and MMSE(assessed after 12 weeks treatment)
Investigators
Study Sites (1)
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