Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease
- Registration Number
- NCT03363269
- Lead Sponsor
- IlDong Pharmaceutical Co Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ID1201 100mg ID1201 - ID1201 200mg ID1201 - ID1201 400mg ID1201 - Placebo ID1201 -
- Primary Outcome Measures
Name Time Method Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at 12 Weeks Baseline, 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Myongji Hospital
🇰🇷Goyang, Korea, Republic of
Daejeon Eulji Medical Center, Eulji University
🇰🇷Daejeon, Korea, Republic of
Hanyang University Hospital
🇰🇷Seoul, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Changwon Fatima Hospital
🇰🇷Changwon, Korea, Republic of
Kangwon National University Hospital
🇰🇷Chuncheon, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Medical Center
🇰🇷Suwon, Korea, Republic of
KunKuk University Hospital
🇰🇷Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Guri, Korea, Republic of