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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

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

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: ID1201 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 12, 2016
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : April 17, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ID1201 100mg Drug: ID1201
Experimental: ID1201 200mg Drug: ID1201
Experimental: ID1201 400mg Drug: ID1201
Placebo Comparator: Placebo Drug: ID1201


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at 12 Weeks [ Time Frame: Baseline, 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363269


Locations
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Sponsors and Collaborators
IlDong Pharmaceutical Co Ltd
More Information
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Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT03363269    
Other Study ID Numbers: ID-BOA-201
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders