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

IlDong Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: ID1201

Study type: Interventional

Funder types: Industry

Identifiers

NCT03363269

ID-BOA-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 4 patient groups, including a placebo group

ID1201 100mg

Experimental group

Treatment:

Drug: ID1201

ID1201 200mg

Experimental group

Treatment:

Drug: ID1201

ID1201 400mg

Experimental group

Treatment:

Drug: ID1201

Placebo

Placebo Comparator group

Treatment:

Drug: ID1201