Alzheimer Disease
Conditions
Keywords
Dementia, Alzheimer Type, Alzheimer Disease
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.
Interventions
DRUGAZD3480
3 oral doses
DRUGDonepezil
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ADAS-Cog | assessed after 12 weeks treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change in ADCS-CGIC, Computerized neurological test battery (CDR) and MMSE | assessed after 12 weeks treatment |
Countries
Austria, Belgium, Bulgaria, Canada, Czechia, Germany, Romania, Russia, Spain, United Kingdom
Outcome results
None listed