Study of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA)
Primary Purpose
Mild-moderate Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Donepezil
DHP1401
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mild-moderate Alzheimer's Disease focused on measuring Alzheimer's disease
Eligibility Criteria
Inclusion Criteria:
- ≥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
Exclusion Criteria:
- 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)
Sites / Locations
- The Catholic University of Korea, Bucheon, ST. Mary's Hospital
- Myongji Hospital
- Seoul National University Bundang Hospital
- Ajou University Medical Center
- Chonnam National University Hospital
- Dong-A University Hospital
- Yeungnam University Medical Center
- Daejeon Eulji Medical Center
- Hanyang University Guri Hospital
- Gachon University Gil Medical Center
- Inha University Hospital
- Chung-ang University Hospital
- Hanyang University Medical Center
- Konkuk University Hospital
- Korea University Anam Hospital
- The Catholic University of Korea, Seoul ST. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Group 1
Group 2
Group 3
Arm Description
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 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 is orally administrated once a day for 24 weeks DHP1401: Placebo is orally administrated in two divided doses a day for 24 weeks
Outcomes
Primary Outcome Measures
Alzheimer's Disease Assessment Scale-cognition Korean version(ADAS-cog)
Secondary Outcome Measures
Clinical Dementia Rating Sum of Box Korean version(CDR-SB)
Neuropsychiatric Inventory-Q Korean version(NPI-Q)
K-MMSE
Korean Mini-Mental State Examination
Korean Instrumental Activity of Daily Living(K-IADL)
Korean Trial Masking Test-elderly's version(K-TMT-e)
Full Information
NCT ID
NCT03055741
First Posted
February 14, 2017
Last Updated
August 19, 2019
Sponsor
Daehwa Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03055741
Brief Title
Study of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA)
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IIb, Clinical Study to Evaluate the Safety and Efficacy of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 28, 2016 (Actual)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daehwa Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild-moderate Alzheimer's Disease
Keywords
Alzheimer's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
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
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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
Arm Title
Group 3
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Donepezil
Other Intervention Name(s)
Aricept®
Intervention Description
5mg or 10mg, once a day, 24 weeks
Intervention Type
Drug
Intervention Name(s)
DHP1401
Other Intervention Name(s)
DHP1401 500mg or 1,000mg
Intervention Description
Total 500mg or 1,000mg was administrated in two divided doses a day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
DHP1401 placebo
Intervention Description
Placebo was administrated in two divided dosed a day for 24 weeks
Primary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-cognition Korean version(ADAS-cog)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical Dementia Rating Sum of Box Korean version(CDR-SB)
Time Frame
6 months
Title
Neuropsychiatric Inventory-Q Korean version(NPI-Q)
Time Frame
6 months
Title
K-MMSE
Description
Korean Mini-Mental State Examination
Time Frame
6 months
Title
Korean Instrumental Activity of Daily Living(K-IADL)
Time Frame
6 months
Title
Korean Trial Masking Test-elderly's version(K-TMT-e)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seol Heui Han, M.D., Ph.D
Organizational Affiliation
Konkuk University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Catholic University of Korea, Bucheon, ST. Mary's Hospital
City
Bucheon-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Myongji Hospital
City
Goyang-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Ajou University Medical Center
City
Suwon-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju-si
State/Province
Jeollanam-do
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Daejeon Eulji Medical Center
City
Daejeon
ZIP/Postal Code
35233
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital
City
Guri-si
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Chung-ang University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
Hanyang University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Konkuk University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul ST. Mary's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA)
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