Study of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA)
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)
1 other identifier
interventional
180
1 country
16
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2016
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 28, 2016
CompletedFirst Submitted
Initial submission to the registry
February 14, 2017
CompletedFirst Posted
Study publicly available on registry
February 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedAugust 20, 2019
August 1, 2019
2.1 years
February 14, 2017
August 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alzheimer's Disease Assessment Scale-cognition Korean version(ADAS-cog)
6 months
Secondary Outcomes (5)
Clinical Dementia Rating Sum of Box Korean version(CDR-SB)
6 months
Neuropsychiatric Inventory-Q Korean version(NPI-Q)
6 months
K-MMSE
6 months
Korean Instrumental Activity of Daily Living(K-IADL)
6 months
Korean Trial Masking Test-elderly's version(K-TMT-e)
6 months
Study Arms (3)
Group 1
EXPERIMENTALdonepezil: 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
EXPERIMENTALdonepezil: 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
PLACEBO COMPARATORdonepezil: 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
Interventions
Eligibility Criteria
You may qualify if:
- ≥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
You may not qualify if:
- 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.)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
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, 35233, 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, 06973, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seol Heui Han, M.D., Ph.D
Konkuk University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2017
First Posted
February 16, 2017
Study Start
December 28, 2016
Primary Completion
February 1, 2019
Study Completion
August 1, 2019
Last Updated
August 20, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share