Efficacy and Safety of N-acetylcysteine (NAC) in Patients With Mild Vascular Cognitive Impairment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Executive Function
研究概览
简要总结
This is a 24-week randomized, double-blind, placebo-controlled parallel group design study involving Vascular cognitive impairment-no dementia (VCIND) patients to evaluate the efficacy and safety of oral NAC supplementation (2,400 mg daily) as an add-on therapy to improve cognitive function in patients undergoing cardiac rehabilitation (CR). The CR program consists of a harmonized aerobic and resistance training in a supervised group setting. Eligible patients will be randomized to receive NAC (four 600 mg capsules given as 2 capsules in the morning and 2 capsules in the evening) or matching placebo capsules. The initial NAC dosage will be 600mg/day (one 600mg capsule in the morning) for the first week, followed by 1,200 mg/day (one 600 mg capsule in the morning, one 600mg capsule in the evening) for the second week, followed by 1,800 mg/day (two 600mg capsules in the morning, one 600mg capsule in the evening) for third week, followed by 2,400mg/day (two 600mg capsules in the morning, two 600mg capsules in the evening) for the following 21 weeks.
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
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 55-80 years.
- •MoCA score of less than
- •Modest deficits (1 SD below population norm) in executive function, memory, processing speed, or working memory based on the 60-minute battery recommended by the NINDS-CSN.
- •Speaks and understands English.
- •Enrollment in the Cardiac Rehabilitation program at the University Health Network Toronto Rehabilitation Institute.
排除标准
- •A history of stroke
- •A history of epilepsy
- •Uncontrolled asthma (requiring hospitalization or ER visit in the last 3 months by patient report)
- •Uncontrolled diabetes (clinical determination)
- •Severe hypo/hypertension (clinical determination)
- •Uncontrolled hypercholesterolemia (clinical determination)
- •Presence of significant medical illnesses (Severely disturbed liver function, Severely disturbed kidney function, Severely disturbed lung function, HIV, HBV and/or HCV infection, Malignant tumors)
- •A current neurological condition (Parkinson's disease, Multiple sclerosis, Significant traumatic brain injury)
- •Major psychiatric condition (Current major depressive disorder, Schizophrenia, Bipolar disorder, Substance use disorder (alcohol abuse, heavy smoking (20 cigarettes or more/day))
- •Contraindication to MRI or MRS (e.g. metal in body, pacemaker).
- •Contraindication to NAC (documented allergy) or allergy to lactose.
- •Daily Nitroglycerin use.
- •Bleeding disorders (e.g. hemophilia, Thrombotic Thrombocytopenic Purpura) and/or elective surgery within 30 days.
- •Volunteers who currently participate in another pharmacological study.
研究组 & 干预措施
N-acetylcysteine
Participants randomized into the N-acetylcysteine arm will be receiving N-acetylcysteine for 24 weeks.
干预措施: N Acetylcysteine (Drug)
Placebo
Participants randomized into the placebo arm will be receiving placebo for 24 weeks.
干预措施: Placebo oral capsule (Other)
结局指标
主要结局
Change in Executive Function
时间窗: 6 months
Differences in executive function composite z scores between experimental and placebo groups at 6 months. Executive function will be based on the trail test B, phonemic fluency, and semantic fluency found in the 60-minute battery recommended by the National Institute of Neurological Disorders and Stroke-Canadian Stroke Network (NINDS-CSN) harmonized standards. A Z-score was computed based on published age-matched norms, and a composite Z-score was calculated. Higher z score represents better cognitive function.
次要结局
- Change in Processing Speed(6 months)
- Change in Memory(6 months)