Alzheimer Disease
Conditions
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.
Interventions
DRUGID1201
Sponsors
IlDong Pharmaceutical Co Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at 12 Weeks | Baseline, 12 weeks |
Countries
South Korea
Outcome results
None listed