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

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

Study Overview

• Status: Recruiting
• Conditions: Moderate-to-severe Alzheimer's Disease
• Intervention / Treatment: Drug: BPDO-1603

• Study Type: Interventional
• Enrollment (Anticipated): 712
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nara LEE; Phone Number: 82-2-2600-3869; Email: nara.lee@hdpharm.co.kr
• Study Contact Backup: Name: Sumin SON; Phone Number: 82-2-2600-3817; Email: smson@myhdpharm.com

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Recruiting
    • Inha University Hospital
    • Contact: Seonghye CHOI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: 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
Placebo Comparator: Arm 2	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in SIB total scores	from baseline to Week 24
CIBIC-plus total score	at Week 24 (Baseline score will be from CIBIS

Collaborators and Investigators

• Sponsor: Hyundai Pharmaceutical Co., LTD.
• Investigators: Principal Investigator: Seonghye CHOI, Inha University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: HT-007-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No