Memory and Antioxidants in Vascular Impairment Trial

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Males or females aged 55-80 years.

• MoCA score of less than 28.

• Modest deficits (1 SD below population norm) in executive function or 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.

• Presence of "diffuse, subcortical cerebrovascular disease", defined as 1) the presence of two or more silent brain infarcts in supratentorial locations or 2) extensive white matter disease (Age-Related White Matter Change [ARWMC] scale score60 of 2 or higher, indicating "beginning confluence of lesions" or greater) in any brain region.

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).

• 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.