Mild-moderate Alzheimer's Disease
Conditions
Keywords
Alzheimer's disease
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
Interventions
DRUGDonepezil
5mg or 10mg, once a day, 24 weeks
DRUGDHP1401
Total 500mg or 1,000mg was administrated in two divided doses a day for 24 weeks
DRUGPlacebo
Placebo was administrated in two divided dosed a day for 24 weeks
Sponsors
Daehwa Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer's Disease Assessment Scale-cognition Korean version(ADAS-cog) | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Dementia Rating Sum of Box Korean version(CDR-SB) | 6 months | — |
| Neuropsychiatric Inventory-Q Korean version(NPI-Q) | 6 months | — |
| K-MMSE | 6 months | Korean Mini-Mental State Examination |
| Korean Instrumental Activity of Daily Living(K-IADL) | 6 months | — |
| Korean Trial Masking Test-elderly's version(K-TMT-e) | 6 months | — |
Countries
South Korea
Outcome results
None listed