Memory and Antioxidants in Vascular Impairment Trial

  • STATUS
    Recruiting
  • days left to enroll
    56
  • participants needed
    60
  • sponsor
    Sunnybrook Health Sciences Centre
Updated on 11 March 2022

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.

Details
Condition Vascular Cognitive Impairment no Dementia
Treatment Placebo oral capsule, N Acetylcysteine, N Acetylcysteine
Clinical Study IdentifierNCT03306979
SponsorSunnybrook Health Sciences Centre
Last Modified on11 March 2022

Eligibility

Yes No Not Sure

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
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