Study of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA)
NCT03055741 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2019-08-20
Summary
The objective of this study is to evaluate the efficacy and safety of DHP1401 in patients with mild-moderate Alzheimer's disease treated with donepezil
Conditions
- Mild-moderate Alzheimer's Disease
Interventions
- DRUG
-
Donepezil
5mg or 10mg, once a day, 24 weeks
- DRUG
-
DHP1401
Total 500mg or 1,000mg was administrated in two divided doses a day for 24 weeks
- DRUG
-
Placebo was administrated in two divided dosed a day for 24 weeks
Sponsors & Collaborators
-
Daehwa Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Seol Heui Han, M.D., Ph.D · Konkuk University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 55 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-28
- Primary Completion
- 2019-02-28
- Completion
- 2019-08-31
Countries
- South Korea
Study Locations
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