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CompletedPhase 2

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

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

Asset

ID1201

Listed sites

20

Recruiting sites

-

Enrollment

116

actual

Study population

Alzheimer’s disease

Key I/E criteria

Alzheimer's diseaseMMSE 16-26

Primary endpoint

ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDID-BOA-201
NCT IDNCT03363269

Timeline

Milestones

Study start2016-04-12actual
Study first posted2017-12-06actual
Primary completion2018-12-31actual
Study completion2019-04-17actual
Last update posted2019-06-04actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

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

Time frame:Baseline, 12 weeks

ADAS-Cog

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.