Study of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA)
NCT ID: NCT03055741
Last Updated: 2019-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2016-12-28
2019-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 1
donepezil: 5mg or 10mg is orally administrated once a day for 24 weeks
DHP1401: Total 500mg is orally administrated in two divided doses a day for 24 weeks
Donepezil
5mg or 10mg, once a day, 24 weeks
DHP1401
Total 500mg or 1,000mg was administrated in two divided doses a day for 24 weeks
Group 2
donepezil: 5mg or 10mg is orally administrated once a day for 24 weeks
DHP1401: Total 1,000mg is orally administrated in two divided doses a day for 24 weeks
Donepezil
5mg or 10mg, once a day, 24 weeks
DHP1401
Total 500mg or 1,000mg was administrated in two divided doses a day for 24 weeks
Group 3
donepezil: 5mg or 10mg is orally administrated once a day for 24 weeks
DHP1401: Placebo is orally administrated in two divided doses a day for 24 weeks
Donepezil
5mg or 10mg, once a day, 24 weeks
Placebo
Placebo was administrated in two divided dosed a day for 24 weeks
Interventions
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Donepezil
5mg or 10mg, once a day, 24 weeks
DHP1401
Total 500mg or 1,000mg was administrated in two divided doses a day for 24 weeks
Placebo
Placebo was administrated in two divided dosed a day for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient who was diagnosed mild to moderate Alzheimer's disease by National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association(NINCDS-ADRDA) or National Institute on Aging-Alzheimer's Association(NIAAA)
3. Korean Mini-Mental State Examination(K-MMSE) score 15 to 26
4. Patient who maintained on donepezil without dose escalation or reduction for at least during 3 months before screening (visit 1)
5. Clinical Dementia Rating(CDR) score 0.5 to 2.0 at screening (visit 1)
6. Written informed consent voluntarily
7. Patient who has a relative/caregiver who support the information of patient's status
8. Patient who are deemed adequate to participate in the clinical trial by the investigator
9. Infertility or patients and his/her spouse consent with contraception during the study period
Exclusion Criteria
2. Structural brain abnormality or impairment
3. Schizophrenia, depressive disorder and bipolar disorder
4. Any neurological disease except Alzheimer' disease (ex. Parkinson's disease, Huntington's disease, brain tumor, normal-pressure hydrocephalus, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, epilepsy, delusion and head injury required hospitalization)
5. History of any cancer within previous 5 years
6. History of stroke within previous 2 years
7. Heart failure required medication or interventional treatment including myocardial infarction, valvular heart disease, arrhythmia within previous 1 year
8. Uncontrollable diabetes
9. Uncontrollable hypertension
10. Abnormal liver or kidney function
11. Patient with significant clinical meaning to affect cognitive function
12. Patient who participated in other clinical trial within previous 3 months or has a plan to participate in other clinical trial during study period
13. History of abuse of a drug or alcohol within previous 2 years
14. Patient who has administrated other acetylcholinesterase inhibitors except donepezil within previous 4 weeks
15. Patient who are deemed inadequate to participate in the clinical trial by the investigator(ex. a illiteracy, etc.)
16. History of hypersensitivity reaction to the main ingredient of the investigational drugs
17. Patient who has administrated other drugs except donepezil for dementia treatment (it is possible to enroll after washout for 28 days)
55 Years
85 Years
ALL
No
Sponsors
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Daehwa Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Seol Heui Han, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Konkuk University Hospital
Locations
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The Catholic University of Korea, Bucheon, ST. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
Myongji Hospital
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Ajou University Medical Center
Suwon, Gyeonggi-do, South Korea
Chonnam National University Hospital
Gwangju-si, Jeollanam-do, South Korea
Dong-A University Hospital
Busan, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Daejeon Eulji Medical Center
Daejeon, , South Korea
Hanyang University Guri Hospital
Guri-si, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
Chung-ang University Hospital
Seoul, , South Korea
Hanyang University Medical Center
Seoul, , South Korea
Konkuk University Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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1401CS-2
Identifier Type: -
Identifier Source: org_study_id
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