Study of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA)
- Conditions
- Mild-moderate Alzheimer's Disease
- Interventions
- Registration Number
- NCT03055741
- Lead Sponsor
- Daehwa Pharmaceutical Co., Ltd.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- ≥55 and ≤85 years of age
- 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)
- Korean Mini-Mental State Examination(K-MMSE) score 15 to 26
- Patient who maintained on donepezil without dose escalation or reduction for at least during 3 months before screening (visit 1)
- Clinical Dementia Rating(CDR) score 0.5 to 2.0 at screening (visit 1)
- Written informed consent voluntarily
- Patient who has a relative/caregiver who support the information of patient's status
- Patient who are deemed adequate to participate in the clinical trial by the investigator
- Infertility or patients and his/her spouse consent with contraception during the study period
- A diagnosis of vascular dementia or dementia by other cause according to the criteria of the NINCDS-ADRDA
- Structural brain abnormality or impairment
- Schizophrenia, depressive disorder and bipolar disorder
- 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)
- History of any cancer within previous 5 years
- History of stroke within previous 2 years
- Heart failure required medication or interventional treatment including myocardial infarction, valvular heart disease, arrhythmia within previous 1 year
- Uncontrollable diabetes
- Uncontrollable hypertension
- Abnormal liver or kidney function
- Patient with significant clinical meaning to affect cognitive function
- Patient who participated in other clinical trial within previous 3 months or has a plan to participate in other clinical trial during study period
- History of abuse of a drug or alcohol within previous 2 years
- Patient who has administrated other acetylcholinesterase inhibitors except donepezil within previous 4 weeks
- Patient who are deemed inadequate to participate in the clinical trial by the investigator(ex. a illiteracy, etc.)
- History of hypersensitivity reaction to the main ingredient of the investigational drugs
- Patient who has administrated other drugs except donepezil for dementia treatment (it is possible to enroll after washout for 28 days)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 DHP1401 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 Group 3 Placebo 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 Group 2 DHP1401 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 Group 1 Donepezil 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 Group 2 Donepezil 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 Group 3 Donepezil 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
- Primary Outcome Measures
Name Time Method Alzheimer's Disease Assessment Scale-cognition Korean version(ADAS-cog) 6 months
- Secondary Outcome Measures
Name Time Method Clinical Dementia Rating Sum of Box Korean version(CDR-SB) 6 months Neuropsychiatric Inventory-Q Korean version(NPI-Q) 6 months Korean Trial Masking Test-elderly's version(K-TMT-e) 6 months K-MMSE 6 months Korean Mini-Mental State Examination
Korean Instrumental Activity of Daily Living(K-IADL) 6 months
Trial Locations
- Locations (16)
Chonnam National University Hospital
🇰🇷Gwangju-si, Jeollanam-do, Korea, Republic of
The Catholic University of Korea, Bucheon, ST. Mary's Hospital
🇰🇷Bucheon-si, Gyeonggi-do, Korea, Republic of
Myongji Hospital
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Ajou University Medical Center
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Daejeon Eulji Medical Center
🇰🇷Daejeon, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Guri-si, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Chung-ang University Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Medical Center
🇰🇷Seoul, Korea, Republic of
Konkuk University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul ST. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of