Memory and Antioxidants in Vascular Impairment Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: N-acetylcysteine Participants randomized into the N-acetylcysteine arm will be receiving N-acetylcysteine for 24 weeks. |
Drug: N Acetylcysteine
Patients will be randomized to receive N Acetylcysteine (NAC) (four 600 mg capsules given as 2 capsules in the morning and 2 capsules in the evening). 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.
Other Names:
|
| Placebo Comparator: Placebo Participants randomized into the placebo arm will be receiving placebo for 24 weeks. |
Other: Placebo oral capsule
Patients will receive four placebo capsules (lactose-based filler) given as 2 capsules in the morning and 2 capsules in the evening, which will be prepared to mimic the weight of the experimental capsules.The initial placebo 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change in executive function [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 found in the 60-minute battery recommended by the National Institute of Neurological Disorders and Stroke-Canadian Stroke Network (NINDS-CSN) harmonized standards.
Secondary Outcome Measures
- Change in processing speed [6 months]
Differences in processing speed composite z scores between experimental and placebo groups at 6 months. Processing speed will be based on the symbol digit modalities test found in the 60-minute battery recommended by the NINDS-CSN.
- Change in memory [6 months]
Differences in memory composite z scores between experimental and placebo groups at 6 months. Memory will be based on the Rey Complex Figure Test found in the 60-minute battery recommended by the NINDS-CSN.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males or females aged 55-80 years.
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MoCA score of less than 28.
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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.
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Speaks and understands English.
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Enrollment in the Cardiac Rehabilitation program at the University Health Network Toronto Rehabilitation Institute.
Exclusion Criteria:
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A history of stroke
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A history of epilepsy
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Uncontrolled asthma (requiring hospitalization or ER visit in the last 3 months by patient report)
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Uncontrolled diabetes (clinical determination)
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Severe hypo/hypertension (clinical determination)
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Uncontrolled hypercholesterolemia (clinical determination)
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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)
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A current neurological condition (Parkinson's disease, Multiple sclerosis, Significant traumatic brain injury)
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Major psychiatric condition (Current major depressive disorder, Schizophrenia, Bipolar disorder, Substance use disorder (alcohol abuse, heavy smoking (20 cigarettes or more/day))
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Contraindication to MRI or MRS (e.g. metal in body, pacemaker).
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Contraindication to NAC (documented allergy) or allergy to lactose.
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Daily Nitroglycerin use.
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Bleeding disorders (e.g. hemophilia, Thrombotic Thrombocytopenic Purpura) and/or elective surgery within 30 days.
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Volunteers who currently participate in another pharmacological study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
Sponsors and Collaborators
- Sunnybrook Health Sciences Centre
Investigators
- Principal Investigator: Krista L Lanctôt, PhD, Sunnybrook Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 241-2017