Study of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA)

Mild-moderate Alzheimer's Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055741
• Other study ID #: 1401CS-2
• Status: Completed
• Phase: Phase 2
• Start date: December 28, 2016
• Est. completion date: August 2019

Study information

• Verified date: August 2019
• Source: Daehwa Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Mild-moderate Alzheimer's Disease

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, Bucheon, ST. Mary's Hospital	Bucheon-si	Gyeonggi-do
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Daejeon Eulji Medical Center	Daejeon
Korea, Republic of	Myongji Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Hanyang University Guri Hospital	Guri-si
Korea, Republic of	Chonnam National University Hospital	Gwangju-si	Jeollanam-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
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	Korea University Anam Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul ST. Mary's Hospital	Seoul
Korea, Republic of	Ajou University Medical Center	Suwon-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Daehwa Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease Assessment Scale-cognition Korean version(ADAS-cog)		6 months
Secondary	Clinical Dementia Rating Sum of Box Korean version(CDR-SB)		6 months
Secondary	Neuropsychiatric Inventory-Q Korean version(NPI-Q)		6 months
Secondary	K-MMSE	Korean Mini-Mental State Examination	6 months
Secondary	Korean Instrumental Activity of Daily Living(K-IADL)		6 months
Secondary	Korean Trial Masking Test-elderly's version(K-TMT-e)		6 months