Alzheimer DiseasePhase 2NCT03363269
Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease
A Phase 2 study testing ID1201 in people with Alzheimer Disease, run by IlDong Pharmaceutical Co Ltd at 20 sites in South Korea.
Trial summary
The objective of this study is to evaluate the safety and efficacy of ID1201 in patients with mild Alzheimer's disease Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- ID1201
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 20 sitesSouth Korea
- Study dates
- 12 Apr 2016to 17 Apr 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
- Patient diagnosed with dementia of Alzheimer's type according to DSM-IV criteria and probable Alzheimer's disease according to the NINCDS-ADRDA
- modified Hachinski Ischemia Scale score of less than or equal to 4
- Mini-Mental State Examination score 16 to 26 and Clinical Dementia Rating-Global Scale score 0.5 to 1
- Amyloid postivie PET image (BAPL score 2 or 3)
- Patients who have not received AChE inhibitors or NMDA antagonist at least for 3 months prior to the screening visit
Who cannot join
- Patients diagnosed or accompanied with Dementia due to other Neurodegenerative disorders other than Alzheimer's disease
- Chronic alcohol and/or drug abuse within the past 5 years
- Subjects who have medical history of significant renal disease (ccr<30ml/min) or hepatic disease( 3*ULN <= ALT or AST)
- Has received choline agonists, anticholinergics, anticonvulsants, antidepressants, antipsychotic drugs, Ginko biloba extract, Vitamin E, hormone replacement therapy etc. in the previous 4 weeks
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
South Korea20 sites
Dong-A University Hospital
Busan
Changwon Fatima Hospital
Changwon
Kangwon National University Hospital
Chuncheon
Daegu Catholic University Medical Center
Daegu
Kyungpook National University Chilgok Hospital
Daegu
Yeungnam University Medical Center
Daegu
Daejeon Eulji Medical Center, Eulji University
Daejeon
Myongji Hospital
Goyang
Hanyang University Guri Hospital
Guri-si
Chonnam National University Hospital
Gwangju
Inha University Hospital
Incheon
Chonbuk National University Hospital
Jeonju
Seoul National University Bundang Hospital
Seongnam-si
Chung-Ang University Hospital
Seoul
Ewha Womans University Mokdong Hospital
Seoul
Hanyang University Hospital
Seoul
Korea University Anam Hospital
Seoul
KunKuk University Hospital
Seoul
Ajou University Medical Center
Suwon
Pusan National University Yangsan Hospital
Yangsan
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease
The objective of this study is to evaluate the safety and efficacy of ID1201 in patients with mild Alzheimer's disease
Read the detailed description
ID1201 is a fruit extract of Melia toosendan. ID1201 alleviates Alzheimer's disease-type pathologies and cognitive deficit through the various actions of its effective components such as α-secretase activation followed to Aβ reduction, RAGE inhibition, neuro-protection, and anti-inflammatory activities.
- Conditions
- Alzheimer Disease
- Being tested
- ID1201
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID1201Drug
| Study group | Role | What they receive |
|---|---|---|
| ID1201 100mg | Experimental | Not described Receives: Drug: ID1201 |
| ID1201 200mg | Experimental | Not described Receives: Drug: ID1201 |
| ID1201 400mg | Experimental | Not described Receives: Drug: ID1201 |
| Placebo | Placebo comparator | Not described Receives: Drug: ID1201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at 12 Weeks
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start12 Apr 2016
- Primary completion31 Dec 2018
- Study completion17 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363269
- Sponsor's protocol ID
- ID-BOA-201
- Status last verified
- Jun 2019
- First submitted
- 30 Nov 2017
- Last updated
- 4 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03363269
- Acronym / sponsor ID
- ID-BOA-201
- Conditions
- Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 6 Dec 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 safety and efficacy of ID1201 in patients with mild Alzheimer's disease
Detailed description
ID1201 is a fruit extract of Melia toosendan. ID1201 alleviates Alzheimer's disease-type pathologies and cognitive deficit through the various actions of its effective components such as α-secretase activation followed to Aβ reduction, RAGE inhibition, neuro-protection, and anti-inflammatory activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ID1201 100mg | Experimental | Drug: ID1201 |
| ID1201 200mg | Experimental | Drug: ID1201 |
| ID1201 400mg | Experimental | Drug: ID1201 |
| Placebo | Placebo comparator | Drug: ID1201 |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient diagnosed with dementia of Alzheimer's type according to DSM-IV criteria and probable Alzheimer's disease according to the NINCDS-ADRDA
- modified Hachinski Ischemia Scale score of less than or equal to 4
- Mini-Mental State Examination score 16 to 26 and Clinical Dementia Rating-Global Scale score 0.5 to 1
- Amyloid postivie PET image (BAPL score 2 or 3)
- Patients who have not received AChE inhibitors or NMDA antagonist at least for 3 months prior to the screening visit
Key exclusion criteria (4 listed)
- Patients diagnosed or accompanied with Dementia due to other Neurodegenerative disorders other than Alzheimer's disease
- Chronic alcohol and/or drug abuse within the past 5 years
- Subjects who have medical history of significant renal disease (ccr<30ml/min) or hepatic disease( 3*ULN <= ALT or AST)
- Has received choline agonists, anticholinergics, anticonvulsants, antidepressants, antipsychotic drugs, Ginko biloba extract, Vitamin E, hormone replacement therapy etc. in the previous 4 weeks
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 |
|---|---|---|
| ID1201 | Drug | ID1201 100mg, ID1201 200mg, ID1201 400mg, Placebo |
Primary outcome
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at 12 Weeks
Time frame: Baseline, 12 weeks
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 4 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
20 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 ID1201 in people with Alzheimer Disease, run by IlDong Pharmaceutical Co Ltd at 20 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 5 inclusion and 4 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 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at 12 Weeks (time frame: Baseline, 12 weeks). 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 4 Jun 2019.