Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease

• Status: Completed
• Trial end date: 2019-04-17
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the safety and efficacy of ID1201 in patients with mild Alzheimer's disease

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IlDong Pharmaceutical Co Ltd

Criteria

Inclusion Criteria:

1. Patient diagnosed with dementia of Alzheimer's type according to DSM-IV criteria and probable Alzheimer's disease according to the NINCDS-ADRDA

2. modified Hachinski Ischemia Scale score of less than or equal to 4

3. Mini-Mental State Examination score 16 to 26 and Clinical Dementia Rating-Global Scale score 0.5 to 1

4. Amyloid postivie PET image (BAPL score 2 or 3)

5. Patients who have not received AChE inhibitors or NMDA antagonist at least for 3 months prior to the screening visit

Exclusion Criteria:

1. Patients diagnosed or accompanied with Dementia due to other Neurodegenerative disorders other than Alzheimer's disease

2. Chronic alcohol and/or drug abuse within the past 5 years

3. Subjects who have medical history of significant renal disease (ccr<30ml/min) or hepatic disease( 3*ULN <= ALT or AST)

4. Has received choline agonists, anticholinergics, anticonvulsants, antidepressants, antipsychotic drugs, Ginko biloba extract, Vitamin E, hormone replacement therapy etc. in the previous 4 weeks