Clinical trial NCT03055741: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mild-moderate Alzheimer's Disease
Keywords: Alzheimer's disease
Lead sponsor: Daehwa Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-02-16
Enrollment: 180
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. ≥55 and ≤85 years of age
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:

1. A diagnosis of vascular dementia or dementia by other cause according to the criteria of the NINCDS-ADRDA
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)

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale-cognition Korean version(ADAS-cog)
timeFrame: 6 months
Secondary outcomes:
measure: Clinical Dementia Rating Sum of Box Korean version(CDR-SB)
timeFrame: 6 months
measure: Neuropsychiatric Inventory-Q Korean version(NPI-Q)
timeFrame: 6 months
measure: K-MMSE
timeFrame: 6 months
measure: Korean Instrumental Activity of Daily Living(K-IADL)
timeFrame: 6 months
measure: Korean Trial Masking Test-elderly's version(K-TMT-e)
timeFrame: 6 months
Other outcomes:
Locations:
city: Bucheon-si
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon, ST. Mary's Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Myongji Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Medical Center
state: Gyeonggi-do
city: Gwangju-si
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Jeollanam-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Daejeon Eulji Medical Center
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
Study officials:
affiliation: Konkuk University Hospital
name: Seol Heui Han, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: