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

Sponsor

Hyundai Pharmaceutical Co., LTD. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04229927

Collaborator

(none)

712

Enrollment

Location

Arms

36.1

Anticipated Duration (Months)

19.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Moderate-to-severe Alzheimer's Disease	Drug: BPDO-1603	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

712 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 27, 2020

Anticipated Primary Completion Date :

Feb 28, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in SIB total scores [from baseline to Week 24]
CIBIC-plus total score [at Week 24 (Baseline score will be from CIBIS]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inha University Hospital	Incheon		Korea, Republic of

Sponsors and Collaborators

Hyundai Pharmaceutical Co., LTD.

Investigators

Principal Investigator: Seonghye CHOI, Inha University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hyundai Pharmaceutical Co., LTD.

ClinicalTrials.gov Identifier:

NCT04229927

Other Study ID Numbers:

HT-007-04

First Posted:

Jan 18, 2020

Last Update Posted:

Apr 22, 2020

Last Verified:

Jan 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Apr 22, 2020