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

NCT ID: NCT03363269

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-12
• Study Completion Date: 2019-04-17

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ID1201 100mg

Group Type: EXPERIMENTAL

ID1201

Intervention Type: DRUG

ID1201 200mg

Group Type: EXPERIMENTAL

ID1201

Intervention Type: DRUG

ID1201 400mg

Group Type: EXPERIMENTAL

ID1201

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

ID1201

Intervention Type: DRUG

Interventions

ID1201

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dong-A University Hospital

Busan, , South Korea

Changwon Fatima Hospital

Changwon, , South Korea

Kangwon National University Hospital

Chuncheon, , South Korea

Daegu Catholic University Medical Center

Daegu, , South Korea

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Yeungnam University Medical Center

Daegu, , South Korea

Daejeon Eulji Medical Center, Eulji University

Daejeon, , South Korea

Myongji Hospital

Goyang, , South Korea

Hanyang University Guri Hospital

Guri-si, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Inha University Hospital

Incheon, , South Korea

Chonbuk National University Hospital

Jeonju, , South Korea

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Chung-Ang University Hospital

Seoul, , South Korea

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Hanyang University Hospital

Seoul, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

KunKuk University Hospital

Seoul, , South Korea

Ajou University Medical Center

Suwon, , South Korea

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Countries

South Korea

Other Identifiers

ID-BOA-201

Identifier Type: -

Identifier Source: org_study_id