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

NCT ID: NCT04229927

Last Updated: 2020-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 712 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-27
• Study Completion Date: 2023-03-01

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

Conditions

Moderate-to-severe Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

BPDO-1603

Intervention Type: 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

Arm 2

Group Type: PLACEBO_COMPARATOR

BPDO-1603

Intervention Type: 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

Interventions

BPDO-1603

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hyundai Pharmaceutical Co., LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seonghye CHOI

Role: PRINCIPAL_INVESTIGATOR

Inha University Hospital

Locations

Inha University Hospital

Incheon, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Nara LEE

Role: CONTACT

nara.lee@hdpharm.co.kr

82-2-2600-3869

Sumin SON

Role: CONTACT

smson@myhdpharm.com

82-2-2600-3817

Facility Contacts

Seonghye CHOI

Role: primary

Other Identifiers

HT-007-04

Identifier Type: -

Identifier Source: org_study_id