Skip to main content
OpenTrials
Completed

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

Completed

Looking for future studies?

Notify Me

Key information

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

Loading trial locations.

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

ID1201

Drug

Primary outcomes

  1. 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.

Published trials that share one or more normalized conditions with this study.