A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 21
- 主要终点
- Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24
研究概览
简要总结
This clinical trial was performed to assess the clinical efficacy and safety of two 4 week treatment courses of daily intravenous administration of Cerebrolysin (20mL [milliliter] IV [intravenous] per day). The study was performed as prospective, randomised, double-blind, placebo-controlled, parallel group, multicentre study with 2 study groups.
Group 1: 20 mL Cerebrolysin and 100 mg (milligram) acetylsalicylic acid Group 2: Placebo (0.9% NaCl [sodium chloride]) and 100 mg acetylsalicylic acid The study drug was given once daily by intravenous infusion (20ml in 250ml saline solution) for 4 weeks on five consecutive days per week. This treatment regimen was repeated after a two-month treatment-free interval. Acetylsalicylic acid was given orally, once daily throughout the study duration of 24 weeks.
Altogether five clinical evaluation visits at Baseline (day 0) and at week 4, 12, 16, and 24 were necessary.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or post-menopausal women between 50 and 85 years
- •Clinical diagnosis of vascular dementia according to NINDS-AIREN criteria
- •CT or MRI results compatible with clinical diagnosis
- •MMSE score between 10 and 24, both inclusive
- •Modified Hachinski Ischemic Score >4
- •Hamilton Depression Scale score of less than or equal to 15
- •Adequate visual and auditory acuity to allow neuropsychological testing
- •Informed consent given by the patient and/or the next-of-kin
排除标准
- •Gastric ulcer associated with intolerance of acetylsalicylic acid treatment
- •Severe psychotic features, schizophrenia, depression, agitation or behavioral problems within the last three months that could lead to difficulty complying with the protocol
- •Any severe systemic illness or unstable medical condition that could lead to difficulty complying with the protocol or significantly limits life span.
- •Patients who in the investigator's opinion, would not comply with study procedures
- •Any significant neurological disease other than vascular dementia, such as Parkinson's disease, epilepsy, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, or multiple sclerosis
- •History of alcohol or substance abuse or dependence within the past two years
- •Patients with a history of systemic cancer within the past two years
- •Severe congestive heart failure or malignant, uncontrollable hypertension
- •Participation in a clinical trial with an investigational drug in the past four weeks
研究组 & 干预措施
Cerebrolysin
干预措施: Cerebrolysin (Drug)
0.9% Saline Solution
干预措施: 0.9% Saline Solution (Drug)
结局指标
主要结局
Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24
时间窗: baseline and week 24
The ADAS-COG+ is a psychometric instrument used to evaluate memory, attention, reasoning, language, orientation and praxis. The score ranges from 0 to 85 with 85 being the worst score. A negative change indicates cognitive improvement.
CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24
时间窗: week 24
This rating scale is based on the health care provider's "general clinical impressions" with the informant input (i.e. family members). It evaluates global function and is scored from 1 (marked improvement) to 7 (marked worsening).
次要结局
- Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart)(week 4, 12, 16)
- Change From Baseline for Original ADAS-COG(week 4, 12, 16, 24)
- CIBIC+ Score(week 4, 12, 16)
- ADAS-COG+ Response(week 4, 12, 16, 24)
- CIBIC+ Response(week 4, 12, 16, 24)
- CIBIS+ (Clinicians Interview-Based Impression of Severity)(week 24)
- Change From Baseline in MMSE (Mini-Mental State Examination) Score(week 4, 12, 16, 24)
- Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale)(week 4, 12, 16, 24)
- Change From Baseline in Trail-making Test(week 4, 12, 16, 24)
- Change From Baseline in Clock-drawing Test(week 4, 12, 16, 24)
- Combined Response, i.e. Response in ADAS-COG+ and CIBIC+(week 4, 12, 16, 24)