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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363269
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

Tracking Information
First Submitted Date  ICMJE November 30, 2017
First Posted Date  ICMJE December 6, 2017
Last Update Posted Date June 4, 2019
Actual Study Start Date  ICMJE April 12, 2016
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2017)		 Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at 12 Weeks [ Time Frame: Baseline, 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE Drug: ID1201
Study Arms  ICMJE
  • Experimental: ID1201 100mg
    Intervention: Drug: ID1201
  • Experimental: ID1201 200mg
    Intervention: Drug: ID1201
  • Experimental: ID1201 400mg
    Intervention: Drug: ID1201
  • Placebo Comparator: Placebo
    Intervention: Drug: ID1201
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2018)		 116
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2017)		 236
Actual Study Completion Date  ICMJE April 17, 2019
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03363269
Other Study ID Numbers  ICMJE ID-BOA-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party IlDong Pharmaceutical Co Ltd
Original Responsible Party Same as current
Current Study Sponsor  ICMJE IlDong Pharmaceutical Co Ltd
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account IlDong Pharmaceutical Co Ltd
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP