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Trial record 31 of 1886 for:    "Alzheimer disease familial"

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

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ClinicalTrials.gov Identifier: NCT03055741
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
Daehwa Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Mild-moderate Alzheimer's Disease Drug: Donepezil Drug: DHP1401 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 28, 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018


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 Name: Aricept®

Drug: DHP1401
Total 500mg or 1,000mg was administrated in two divided doses a day for 24 weeks
Other Name: 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 Name: Aricept®

Drug: DHP1401
Total 500mg or 1,000mg was administrated in two divided doses a day for 24 weeks
Other Name: 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 Name: Aricept®

Drug: Placebo
Placebo was administrated in two divided dosed a day for 24 weeks
Other Name: DHP1401 placebo




Primary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale-cognition Korean version(ADAS-cog) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Clinical Dementia Rating Sum of Box Korean version(CDR-SB) [ Time Frame: 6 months ]
  2. Neuropsychiatric Inventory-Q Korean version(NPI-Q) [ Time Frame: 6 months ]
  3. K-MMSE [ Time Frame: 6 months ]
    Korean Mini-Mental State Examination

  4. Korean Instrumental Activity of Daily Living(K-IADL) [ Time Frame: 6 months ]
  5. Korean Trial Masking Test-elderly's version(K-TMT-e) [ Time Frame: 6 months ]


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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055741


Contacts
Contact: Seol Heui Han, M.D., Ph.D 82-2-2030-7007 20050102@kuh.ac.kr

Locations
Korea, Republic of
The Catholic University of Korea, Bucheon, ST. Mary's Hospital Recruiting
Bucheon-si, Gyeonggi-do, Korea, Republic of
Contact: Yong-Soo Shim, M.D., Ph.D.    82-32-340-7094    ysshim@catholic.ac.kr   
Myongji Hospital Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of
Contact: Hyun Jeong Han, M.D., Ph.D.    82-31-810-5403    neurohan@mjh.or.kr   
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of
Contact: SangYun Kim, M.D., Ph.D.    82-31-787-7462    neuroksy@snu.ac.kr   
Ajou University Medical Center Recruiting
Suwon-si, Gyeonggi-do, Korea, Republic of
Contact: Tae Sung Lim, M.D., Ph.D.    82-31-219-4493    lts0204@aumc.ac.kr   
Chonnam National University Hospital Recruiting
Gwangju-si, Jeollanam-do, Korea, Republic of
Contact: Byeong Chae Kim, M.D., Ph.D.    82-62-220-6123    byeckim@gmail.com   
Dong-A University Hospital Recruiting
Busan, Korea, Republic of
Contact: Kyung Won Park, M.D., Ph.D.    82-51-240-2966    neuropark@dau.ac.kr   
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of
Contact: Kee Hyung Park, M.D., Ph. D.    82-32-460-8683    khpark@gachon.ac.kr   
Inha University Hospital Recruiting
Incheon, Korea, Republic of
Contact: Seong-Hye Choi, M.D., Ph.D.    82-32-890-3659    seonghye@inha.ac.kr   
Hanyang University Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Hee-Jin Kim, M.D., Ph.D.    82-2-2290-8374    hyumcbrain@hanyang.ac.kr   
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kun-Woo Park, M.D., Ph.D.    82-2-926-5347    kunu@korea.ac.kr   
The Catholic University of Korea, Seoul ST. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Dong-Won Yang, M.D., Ph.D.    82-2-2258-6077    neuroman@catholic.ac.kr   
Sponsors and Collaborators
Daehwa Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Seol Heui Han, M.D., Ph.D Konkuk University Hospital

Responsible Party: Daehwa Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03055741     History of Changes
Other Study ID Numbers: 1401CS-2
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Daehwa Pharmaceutical Co., Ltd.:
Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents