Efficacy and Safety of N-acetylcysteine (NAC) in Patients With Mild Vascular Cognitive Impairment
Overview
- Phase
- Phase 2
- Intervention
- N Acetylcysteine
- Conditions
- Vascular Cognitive Impairment no Dementia
- Sponsor
- Sunnybrook Health Sciences Centre
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in Executive Function
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Arms & Interventions
N-acetylcysteine
Participants randomized into the N-acetylcysteine arm will be receiving N-acetylcysteine for 24 weeks.
Intervention: N Acetylcysteine
Placebo
Participants randomized into the placebo arm will be receiving placebo for 24 weeks.
Intervention: Placebo oral capsule
Outcomes
Primary Outcomes
Change in Executive Function
Time Frame: 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.
Secondary Outcomes
- Change in Processing Speed(6 months)
- Change in Memory(6 months)