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

Daehwa Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Mild-moderate Alzheimer's Disease

Treatments: Drug: DHP1401; Drug: Donepezil; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03055741

1401CS-2

Details and patient eligibility

About

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

Enrollment: 180 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

180 participants in 3 patient groups, including a placebo group

Group 1

Experimental group

Description:

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

Treatment:

Drug: Donepezil

Drug: DHP1401

Group 2

Experimental group

Description:

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

Treatment:

Drug: Donepezil

Drug: DHP1401

Group 3

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Donepezil