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
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Alzheimer's Disease Assessment Scale- Cognitive (ADAS-cog) score at Week-12 visit compared to baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
研究组 & 干预措施
BAC treatment group
BAC, topical application on external nasal skin, scalp, and neck, 30g/day, 2 times daily, for 12 weeks
干预措施: BAC (Drug)
BAC Matched vehicle
BAC Matched vehicle, topical application on external nasal skin, scalp, and neck, 30g/day, 2 times daily, for 12 weeks
干预措施: BAC Matched Vehicle (Other)
结局指标
主要结局
Change in Alzheimer's Disease Assessment Scale- Cognitive (ADAS-cog) score at Week-12 visit compared to baseline
时间窗: Weeks 12
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.
次要结局
- Change in physical examination results(Weeks 4, 8, 12)
- Change in ADAS-cog score at all post treatment visits (except Week-12 visit) compared to baseline(Weeks 4, 8, 12)
- Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) score at all post treatment visits(Weeks 4, 8, 12)
- Change in Activities of Daily Living (ADL) score at all post treatment visits compared to baseline(Weeks 4, 8, 12)
- Adverse event incidence(Baseline, Weeks 4, 8, 12)
- Net change from baseline in laboratory test results(Weeks 4, 8, 12)
- Change in Mini-Mental State Examination (MMSE) score at all post treatment visits compared to baseline(Weeks 4, 8, 12)
- Net change from baseline in vital signs(Weeks 4, 8, 12])
- Change in Neuropsychiatric Inventory (NPI) score at all post treatment visits compared to baseline(Weeks 4, 8, 12)