NCT Number: NCT03363269
Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease
The objective of this study is to evaluate the safety and efficacy of ID1201 in patients with mild Alzheimer's disease
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Conditions
Age range
55 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Dong-A University Hospital, Busan, South Korea
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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
Treatment and study plan
Primary outcomes
-
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at 12 Weeks
Time frame: Baseline, 12 weeks
Sponsors and collaborators
Lead sponsor
IlDong Pharmaceutical Co Ltd
Industry
Registry information
Official study title
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease
Important dates
- Study start
- 2016
- Primary completion
- 2018
- Study completion
- 2019
- First posted
- Dec 6, 2017
- Registry last updated
- Jun 4, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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