← Trials/Trial dossier/NCT03363269
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
Lead sponsor
Asset
ID1201
Listed sites
20
Recruiting sites
-
Enrollment
116
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•MMSE 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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointChange 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 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.