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

Study Overview
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Brief Summary
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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

Official Title
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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
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Moderate-to-severe Alzheimer's Disease

Intervention / Treatment
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* Drug: BPDO-1603


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: BPDO-1603<br>* 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<br>|
| Placebo Comparator: Arm 2<br> | Drug: BPDO-1603<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |