drugset / Trial / NCT03306979

Memory and Antioxidants in Vascular Impairment Trial

NCT03306979

Phase 2 Completed 60 enrolled Sunnybrook Health Sciences Centre
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2018-04-30
Primary completion
2023-09-27
Completion
2023-09-27

Drugs

EvaluationDrugModalityDoseRoute
Comparator N-acetylcysteine Small molecule 2400 mg Oral