Mild-moderate Alzheimer's DiseasePhase 2NCT03055741
Study of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA)
A Phase 2 study testing Donepezil and DHP1401 in people with Mild-moderate Alzheimer's Disease, run by Daehwa Pharmaceutical Co., Ltd. at 16 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild-moderate Alzheimer's Disease
- What is being tested?
- Donepezil and DHP1401
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 16 sitesSouth Korea
- Study dates
- 28 Dec 2016to Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
South Korea16 sites
The Catholic University of Korea, Bucheon, ST. Mary's Hospital
Bucheon-si, Gyeonggi-do
Dong-A University Hospital
Busan
Yeungnam University Medical Center
Daegu
Daejeon Eulji Medical Center
Daejeon, 35233
Myongji Hospital
Goyang-si, Gyeonggi-do
Hanyang University Guri Hospital
Guri-si
Chonnam National University Hospital
Gwangju-si, Jeollanam-do
Gachon University Gil Medical Center
Incheon
Inha University Hospital
Incheon
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
Chung-ang University Hospital
Seoul, 06973
Hanyang University Medical Center
Seoul
Konkuk University Hospital
Seoul
Korea University Anam Hospital
Seoul
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul
Ajou University Medical Center
Suwon, Gyeonggi-do
About this study
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(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
- Conditions
- Mild-moderate Alzheimer's Disease
- Being tested
- Donepezil, DHP1401, Placebo
- Keywords
- Alzheimer's disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Also called Aricept®
5mg or 10mg, once a day, 24 weeks
DHP1401Drug
Also called DHP1401 500mg or 1,000mg
Total 500mg or 1,000mg was administrated in two divided doses a day for 24 weeks
PlaceboDrug
Also called DHP1401 placebo
Placebo was administrated in two divided dosed a day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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 Receives: Drug: Donepezil; Drug: DHP1401 |
| Group 2 | Experimental | 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 Receives: Drug: Donepezil; Drug: DHP1401 |
| Group 3 | Placebo comparator | 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 Receives: Drug: Donepezil; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale-cognition Korean version(ADAS-cog)
Measured: 6 months
Secondary outcomes (5)
Clinical Dementia Rating Sum of Box Korean version(CDR-SB)
Measured: 6 months
Neuropsychiatric Inventory-Q Korean version(NPI-Q)
Measured: 6 months
K-MMSE
Korean Mini-Mental State Examination
Measured: 6 months
Korean Instrumental Activity of Daily Living(K-IADL)
Measured: 6 months
Korean Trial Masking Test-elderly's version(K-TMT-e)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start28 Dec 2016
- Primary completionFeb 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild-moderate Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daehwa Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seol Heui Han, M.D., Ph.D, Principal investigator, Konkuk University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055741
- Sponsor's protocol ID
- 1401CS-2
- Status last verified
- Aug 2019
- First submitted
- 14 Feb 2017
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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(DRAMA)
- ClinicalTrials.gov ID
- NCT03055741
- Acronym / sponsor ID
- 1401CS-2
- Conditions
- Mild-moderate Alzheimer's Disease
- Keywords
- Alzheimer's disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Daehwa Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2016 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Donepezil, Drug: DHP1401donepezil: 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 |
| Group 2 | Experimental | Drug: Donepezil, Drug: DHP1401donepezil: 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 |
| Group 3 | Placebo comparator | Drug: Donepezil, Drug: Placebodonepezil: 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 |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DonepezilAlso: Aricept®5mg or 10mg, once a day, 24 weeks | Drug | Group 1, Group 2, Group 3 |
| DHP1401Also: DHP1401 500mg or 1,000mgTotal 500mg or 1,000mg was administrated in two divided doses a day for 24 weeks | Drug | Group 1, Group 2 |
| PlaceboAlso: DHP1401 placeboPlacebo was administrated in two divided dosed a day for 24 weeks | Drug | Group 3 |
Primary outcome
Alzheimer's Disease Assessment Scale-cognition Korean version(ADAS-cog)
Time frame: 6 months
5 secondary outcomes
Clinical Dementia Rating Sum of Box Korean version(CDR-SB)
Time frame: 6 months
Neuropsychiatric Inventory-Q Korean version(NPI-Q)
Time frame: 6 months
K-MMSE
Time frame: 6 months
Korean Instrumental Activity of Daily Living(K-IADL)
Time frame: 6 months
Korean Trial Masking Test-elderly's version(K-TMT-e)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seol Heui Han, M.D., Ph.D principal investigator
Konkuk University Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Donepezil and DHP1401 in people with Mild-moderate Alzheimer's Disease, run by Daehwa Pharmaceutical Co., Ltd. at 16 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's Disease Assessment Scale-cognition Korean version(ADAS-cog) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.