Memory and Antioxidants in Vascular Impairment Trial

Sunnybrook Health Sciences Centre

Status and phase: Completed; Phase 2

Conditions: Vascular Cognitive Impairment no Dementia

Treatments: Drug: N Acetylcysteine; Other: Placebo oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03306979

241-2017

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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, 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).
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

N-acetylcysteine

Active Comparator group

Description:

Participants randomized into the N-acetylcysteine arm will be receiving N-acetylcysteine for 24 weeks.

Treatment:

Drug: N Acetylcysteine

Placebo

Placebo Comparator group

Description:

Participants randomized into the placebo arm will be receiving placebo for 24 weeks.

Treatment:

Other: Placebo oral capsule