NCT03363269

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_2 alzheimer-disease

Timeline
Completed

Started Apr 2016

Typical duration for phase_2 alzheimer-disease

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2019

Completed
Last Updated

June 4, 2019

Status Verified

June 1, 2019

Enrollment Period

2.7 years

First QC Date

November 30, 2017

Last Update Submit

June 3, 2019

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at 12 Weeks

    Baseline, 12 weeks

Study Arms (4)

ID1201 100mg

EXPERIMENTAL
Drug: ID1201

ID1201 200mg

EXPERIMENTAL
Drug: ID1201

ID1201 400mg

EXPERIMENTAL
Drug: ID1201

Placebo

PLACEBO COMPARATOR
Drug: ID1201

Interventions

ID1201DRUG
ID1201 100mgID1201 200mgID1201 400mgPlacebo

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Dong-A University Hospital

Busan, South Korea

Location

Changwon Fatima Hospital

Changwon, South Korea

Location

Kangwon National University Hospital

Chuncheon, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Daejeon Eulji Medical Center, Eulji University

Daejeon, South Korea

Location

Myongji Hospital

Goyang, South Korea

Location

Hanyang University Guri Hospital

Guri-si, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Chung-Ang University Hospital

Seoul, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Hanyang University Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

KunKuk University Hospital

Seoul, South Korea

Location

Ajou University Medical Center

Suwon, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 6, 2017

Study Start

April 12, 2016

Primary Completion

December 31, 2018

Study Completion

April 17, 2019

Last Updated

June 4, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(20)