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

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Mild-moderate Alzheimer's Disease

Intervention / Treatment
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* Drug: Donepezil
* Drug: DHP1401
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease