---
title: "BPDO-1603 Intervention Trial in Patients With Moderate-to-severe Alzheimer's Disease"
nct_id: NCT04229927
overall_status: UNKNOWN
phase: PHASE3
sponsor: Hyundai Pharmaceutical Co., LTD.
study_type: INTERVENTIONAL
primary_condition: "Moderate-to-severe Alzheimer's Disease"
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04229927.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04229927"
ct_last_update_post_date: 2020-04-22
last_seen_at: "2026-05-12T07:02:59.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# BPDO-1603 Intervention Trial in Patients With Moderate-to-severe Alzheimer's Disease

**Official Title:** 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

**NCT ID:** [NCT04229927](https://clinicaltrials.gov/study/NCT04229927)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 712
- **Lead Sponsor:** Hyundai Pharmaceutical Co., LTD.
- **Conditions:** Moderate-to-severe Alzheimer's Disease
- **Start Date:** 2020-02-27
- **Completion Date:** 2023-03-01
- **CT.gov Last Update:** 2020-04-22

## Brief Summary

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

## Eligibility

- **Minimum age:** 45 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Arm 1** (EXPERIMENTAL)
- **Arm 2** (PLACEBO_COMPARATOR)

## Interventions

- **BPDO-1603** (DRUG) — Arm1 : 1 tablet of the test drug, and 1 tablet of placebo reference drug

Arm2 : 1 tablet of the reference drug, and 1 tablet of placebo test drug

## Primary Outcomes

- **Change in SIB total scores** _(time frame: from baseline to Week 24)_
- **CIBIC-plus total score** _(time frame: at Week 24 (Baseline score will be from CIBIS)_

## Locations (1)

- Inha University Hospital, Incheon, South Korea — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.inha university hospital|incheon||south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04229927.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04229927*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*