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)

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

Study Overview

• Status: Completed
• Conditions: Mild-moderate Alzheimer's Disease
• Intervention / Treatment: Drug: Donepezil; Drug: DHP1401; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Dong-A University Hospital
  • Daegu, Korea, Republic of
    • Yeungnam University Medical Center
  • Daejeon, Korea, Republic of, 35233
    • Daejeon Eulji Medical Center
  • Guri-si, Korea, Republic of
    • Hanyang University Guri Hospital
  • Incheon, Korea, Republic of
    • Inha University Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of, 06973
    • Chung-Ang 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
    • Hanyang University Medical Center
  • Seoul, Korea, Republic of
    • Konkuk University Hospital
  • Gyeonggi-do
    • Bucheon-si, Gyeonggi-do, Korea, Republic of
      • The Catholic University of Korea, Bucheon, St. Mary's Hospital
    • Goyang-si, Gyeonggi-do, Korea, Republic of
      • Myongji Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of
      • Seoul National University Bundang Hospital
    • Suwon-si, Gyeonggi-do, Korea, Republic of
      • Ajou University Medical Center
  • Jeollanam-do
    • Gwangju-si, Jeollanam-do, Korea, Republic of
      • Chonnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 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	Drug: Donepezil; 5mg or 10mg, once a day, 24 weeks; Other Names: Aricept®; Drug: DHP1401; Total 500mg or 1,000mg was administrated in two divided doses a day for 24 weeks; Other Names: DHP1401 500mg or 1,000mg
Experimental: Group 2; 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	Drug: Donepezil; 5mg or 10mg, once a day, 24 weeks; Other Names: Aricept®; Drug: DHP1401; Total 500mg or 1,000mg was administrated in two divided doses a day for 24 weeks; Other Names: DHP1401 500mg or 1,000mg
Placebo Comparator: Group 3; 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	Drug: Donepezil; 5mg or 10mg, once a day, 24 weeks; Other Names: Aricept®; Drug: Placebo; Placebo was administrated in two divided dosed a day for 24 weeks; Other Names: DHP1401 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Alzheimer's Disease Assessment Scale-cognition Korean version(ADAS-cog)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Dementia Rating Sum of Box Korean version(CDR-SB)		6 months
Neuropsychiatric Inventory-Q Korean version(NPI-Q)		6 months
K-MMSE	Korean Mini-Mental State Examination	6 months
Korean Instrumental Activity of Daily Living(K-IADL)		6 months
Korean Trial Masking Test-elderly's version(K-TMT-e)		6 months

Collaborators and Investigators

• Sponsor: Daehwa Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Seol Heui Han, M.D., Ph.D, Konkuk University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2016
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Alzheimer's disease
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: 1401CS-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No