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UnknownPhase 3

BPDO-1603 Intervention Trial in Patients With Moderate-to-severe Alzheimer's Disease

A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of BPDO-1603 in Patients With Moderate-to-severe Alzheimer's Disease

Asset

BPDO-1603

Listed sites

1

Recruiting sites

1

Enrollment

712

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 5-20•AD symptomatic therapy: stable ≥12 weeks

Primary endpoints

•SIB total scores•CIBIC-plus total score

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 IDHT-007-04
NCT IDNCT04229927

Timeline

Milestones

Study first posted2020-01-18actual
Study start2020-02-27actual
Last update posted2020-04-22actual
Primary completion2022-02-28estimated
Study completion2023-03-01estimated

Assets

Drug assets

BPDO-1603

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age45 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•A voluntary, written informed consent from the patient or the patient´s representative.
•Male or female patients ≥ 45 years of age as of the date of informed consent.
•Diagnosed with probable AD according to the National Institute on Aging-Alzheimer's Association [NIA-AA (2011)] criteria.
•MMSE score of ≥ 5 and ≤ 20 during screening period.
•CDR-GS of 2 ~ 3 or GDS of 4 ~ 7 during screening period.
•Ongoing cholinesterase inhibitor therapy with stable dose of 10 mg/day donepezil hydrochloride for more than 12 weeks (inclusive) prior to screening, and can continue this therapy until randomization without any change in the dosage regimen of donepezil hydrochloride

Exclusion criteria

•Magnetic resonance imaging (MRI) or computed tomography (CT) findings obtained within the past 12 months (ie, 48 weeks) from screening or at screening, as a cause of dementia other than probable AD.
•History of other organic disease, such as vascular dementia, CNS infections (e.g., human immunodeficiency virus [HIV], syphilis), head injury, Creutzfeldt-Jakob disease, Niemann-Pick's disease, Huntington's disease, Parkinson's disease, epilepsy, or stroke.
•Evidence of other neurological disorders which include seizure disorder that may interfere with the patient's cognition or ability to perform the study procedures.
•Use of Memantine Hydrochloride within 1 month prior to screening

Endpoints (2)

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.

Coverage by outcome category

Global cognition
1
Other clinical outcomes
1

Global cognition

1 endpoint
Primary/protocol endpoint

Change in SIB total scores

Time frame:from baseline to Week 24

change from baseline, improvement

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

CIBIC-plus total score

Time frame:at Week 24 (Baseline score will be from CIBIS

descriptive

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.