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

August 19, 2019 updated by: Daehwa Pharmaceutical Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Alzheimer's Disease Assessment Scale-cognition Korean version(ADAS-cog)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Dementia Rating Sum of Box Korean version(CDR-SB)
Time Frame: 6 months
6 months
Neuropsychiatric Inventory-Q Korean version(NPI-Q)
Time Frame: 6 months
6 months
K-MMSE
Time Frame: 6 months
Korean Mini-Mental State Examination
6 months
Korean Instrumental Activity of Daily Living(K-IADL)
Time Frame: 6 months
6 months
Korean Trial Masking Test-elderly's version(K-TMT-e)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daehwa Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seol Heui Han, M.D., Ph.D, Konkuk University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 28, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1401CS-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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