BAC in Patient With Alzheimer's Disease or Vascular Dementia

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the efficacy of BAC patients with Alzheimer's disease or vascular dementia.The secondary objective of this study is to evaluate the safety of BAC patients with Alzheimer's disease or vascular dementia.

Detailed Description
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This study is designed as a randomized, double-blind, vehicle-controlled and parallel trial to evaluate the efficacy and safety of BAC in patients with Alzheimer's disease or vascular dementia. The investigation product, BAC, is a potential anti-inflammatory agent consisted of Multi-Glycan Complex (MGC) from the Soybean extract. It aims to reduce the neruoinflammation in the Alzhemimer's disease and vascular dementia. Eligible patients will be randomly assigned to receive either one of topical application of BAC or BAC matched vehicle, topical application on external nasal skin, scalp, and neck, 30mL/day, 2 times daily. The treatment duration for each patient is 12 weeks, which consists of 6 visits located at Screening, Baseline (Week 0), Weeks -2, -4, -8, and -12. During the treatment period, patients may continue to receive routinely used medications or treatments for Alzheimer's disease or vascular dementia except those prohibited under this protocol.

Official Title
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A Randomized, Double-Blind, Vehicle-Controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of BAC in Patient With Alzheimer's Disease or Vascular Dementia

Conditions
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Alzheimer's Disease, Vascular Dementia

Intervention / Treatment
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* Drug: BAC
* Other: BAC Matched Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient is eligible for the study if all of the following apply: With either gender aged at least 40 years old With a diagnosis of one of the following disease i. Vascular dementia according to the NINDS-AIREN International Workshop criteria or ii. Alzheimer's disease according to the NIAAA criteria iii. Mixed dementia (possible Alzheimer's disease with cerebrovascular disease) according to the NIAAA criteria Note: NINDS-AIREN: National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherche et l'Enseignement en Neurosciences NIAAA: National Institute on Aging-Alzheimer's Association With mild-to-moderate dementia (score of the Mini-Mental State Examination (MMSE) defined as between 10 to 24) Able to read, write, communicate, and understand cognitive testing instructions Having a responsible caregiver who spends adequate time daily with the patient; the caregiver will accompany the patient to all clinic visits during the study and supervise all study dosing requirements and concomitant medications Signed, by patients and the responsible caregiver, the written informed consent form Exclusion Criteria: With large-artery stroke (thrombotic stroke) With radiological evidence of other brain disorders (subdural hematoma, post-traumatic / post-surgery) With dementia caused by other brain diseases except Alzheimer's disease and vascular dementia (e.g. Parkinson's disease, demyelinated disease of the central nervous system, tumor, hydrocephalus, head injury, central nervous system infection including syphilis, acquired immune deficiency syndrome, etc.) With clinical evidence of pulmonary, hepatic, gastrointestinal, metabolic, endocrine or other life threatening diseases judged by investigators not suitable to enter the study With clinically unstable hypertension, diabetes mellitus, and cardiac disease for the last 3 months With history of stroke and hospitalized for stroke in the previous 3 months With history of alcohol or drug abuse With one of the following abnormal laboratory parameters: hemoglobin < 10 mg/dL or platelet < 100*109/L; creatinine or total bilirubin more than 1.5 times the upper limit value; alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphates (ALP), or γ-glutamyl transferase (γ-GT) more than 2 times the upper limit of normal With depression, not well-controlled with medications. With any uncontrolled illness judged by the investigator that entering the trial may be detrimental to the patient With known or suspected hypersensitivity to any ingredients of study product and vehicle Pregnant or lactating or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period Enrollment in any investigational drug trial within 4 weeks before entering this study

Ages Eligible for Study
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Minimum Age: 40 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BAC treatment group<br>BAC, topical application on external nasal skin, scalp, and neck, 30g/day, 2 times daily, for 12 weeks | Drug: BAC<br>* (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof)<br>* Other names: CSTC1-BAC;|
| Placebo Comparator: BAC Matched vehicle<br>BAC Matched vehicle, topical application on external nasal skin, scalp, and neck, 30g/day, 2 times daily, for 12 weeks | Other: BAC Matched Vehicle<br>* BAC Matched Vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Alzheimer's Disease Assessment Scale- Cognitive (ADAS-cog) score at Week-12 visit compared to baseline | The Alzheimer's Disease Assessment Scale- Cognitive (ADAS-Cog) Subscale test is the standard assessment tool and one of the most popular cognitive testing instrument in clinical trials. | Weeks 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ADAS-cog score at all post treatment visits (except Week-12 visit) compared to baseline | The Alzheimer's Disease Assessment Scale- Cognitive (ADAS-Cog) Subscale test is the standard assessment tool and one of the most popular cognitive testing instrument in clinical trials. | Weeks 4, 8, 12 | 
| Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) score at all post treatment visits | This is a global measure of detectable change in cognition, function and behavior. | Weeks 4, 8, 12 | 
| Change in Activities of Daily Living (ADL) score at all post treatment visits compared to baseline | An inventory of informant based items to assess activities of daily living and instrumental activities of daily living, i.e. functional performance, of Alzheimer's disease (AD). | Weeks 4, 8, 12 | 
| Change in Mini-Mental State Examination (MMSE) score at all post treatment visits compared to baseline | This is a multi-item instrument that examines orientation, registration, attention, calculation, recall, visuospatial abilities and language. The score ranges from 0 to 30, with higher scores indicating better cognitive function. MMSE was measured at Screening, Randomization/Baseline, Week 4, Week 8, and Week 12. | Weeks 4, 8, 12 | 
| Change in Neuropsychiatric Inventory (NPI) score at all post treatment visits compared to baseline | The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 12 behavioral domains (12-item NPI) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. NPI-12 Caregiver Distress score is scored for associated caregiver distress from 0 (no distress) to 5 (very severe or extreme). Higher scores indicate greater distress. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12. | Weeks 4, 8, 12 | 
| Adverse event incidence | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study medication, whether or not related to the study medication. Laboratory abnormalities should not be recorded as AEs unless determined to be clinically significant by the Investigator. The number of participants with adverse events within the BAC and placebo groups was determined. | Baseline, Weeks 4, 8, 12 | 
| Change in physical examination results | Items include general appearance, skin, eyes, ears, nose, throat, head and neck, heart, joints, chest and lungs, abdomen, lymph nodes, musculoskeletal, nervous system, and others. | Weeks 4, 8, 12 | 
| Net change from baseline in laboratory test results | Items include blood pressures, pulse rate, respiratory rate, and body temperature. | Weeks 4, 8, 12 | 
| Net change from baseline in vital signs | Items include 1. hematology: hemoglobin, hematocrit, red blood cell (RBC), platelet, white blood cell (WBC) with differential counts; 2. Biochemistry: aspartate aminotransferase (AST), alanine aminotransferase (ALT), γ-glutamyl transferase (γ-GT), serum creatinine, blood urea nitrogen (BUN), albumin, total protein, alkaline phosphatase, total bilirubin | Weeks 4, 8, 12] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's Disease, Vascular Dementia