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
1 other identifier
interventional
712
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2020
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
February 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedApril 22, 2020
January 1, 2020
2 years
January 13, 2020
April 20, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Change in SIB total scores
from baseline to Week 24
CIBIC-plus total score
at Week 24 (Baseline score will be from CIBIS
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Inha University Hospital
Incheon, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Seonghye CHOI
Inha University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2020
First Posted
January 18, 2020
Study Start
February 27, 2020
Primary Completion
February 28, 2022
Study Completion
March 1, 2023
Last Updated
April 22, 2020
Record last verified: 2020-01