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

Hyundai Pharmaceutical Co., LTD.1 site in 1 country712 target enrollmentFebruary 27, 2020

ConditionsModerate-to-severe Alzheimer's Disease

InterventionsBPDO-1603

DrugsBPDO-1603

Overview

Phase: Phase 3
Intervention: BPDO-1603
Conditions: Moderate-to-severe Alzheimer's Disease
Sponsor: Hyundai Pharmaceutical Co., LTD.
Enrollment: 712
Locations: 1
Primary Endpoint: Change in SIB total scores
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

February 27, 2020

End Date

March 1, 2023

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hyundai Pharmaceutical Co., LTD.

Responsible Party

Sponsor

Eligibility Criteria

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