Status:
COMPLETED
Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease
Lead Sponsor:
IlDong Pharmaceutical Co Ltd
Conditions:
Alzheimer Disease
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 12 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2019
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT03363269
Start Date
April 12 2016
End Date
April 17 2019
Last Update
June 4 2019
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Dong-A University Hospital
Busan, South Korea
2
Changwon Fatima Hospital
Changwon, South Korea
3
Kangwon National University Hospital
Chuncheon, South Korea
4
Daegu Catholic University Medical Center
Daegu, South Korea