Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ID1201
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Dong-A University Hospital
- Changwon Fatima Hospital
- Kangwon National University Hospital
- Daegu Catholic University Medical Center
- Kyungpook National University Chilgok Hospital
- Yeungnam University Medical Center
- Daejeon Eulji Medical Center, Eulji University
- Myongji Hospital
- Hanyang University Guri Hospital
- Chonnam National University Hospital
- Inha University Hospital
- Chonbuk National University Hospital
- Seoul National University Bundang Hospital
- Chung-Ang University Hospital
- Ewha Womans University Mokdong Hospital
- Hanyang University Hospital
- Korea University Anam Hospital
- KunKuk University Hospital
- Ajou University Medical Center
- Pusan National University Yangsan Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
ID1201 100mg
ID1201 200mg
ID1201 400mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at 12 Weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT03363269
First Posted
November 30, 2017
Last Updated
June 3, 2019
Sponsor
IlDong Pharmaceutical Co Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03363269
Brief Title
Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 12, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
April 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IlDong Pharmaceutical Co Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ID1201 100mg
Arm Type
Experimental
Arm Title
ID1201 200mg
Arm Type
Experimental
Arm Title
ID1201 400mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ID1201
Primary Outcome Measure Information:
Title
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at 12 Weeks
Time Frame
Baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Changwon Fatima Hospital
City
Changwon
Country
Korea, Republic of
Facility Name
Kangwon National University Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Daejeon Eulji Medical Center, Eulji University
City
Daejeon
Country
Korea, Republic of
Facility Name
Myongji Hospital
City
Goyang
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital
City
Guri
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hanyang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
KunKuk University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Medical Center
City
Suwon
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease
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