Phase 2
N=59
Memory and Antioxidants in Vascular Impairment Trial
Vascular Cognitive Impairment no Dementia
Bottom Line
View on ClinicalTrials.gov: NCT03306979 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Change in Executive Function — 0.32; 0.36 z-score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N Acetylcysteine (Drug); Placebo oral capsule (Other)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Sunnybrook Health Sciences Centre
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Executive Function |
0.32; 0.36 | — |
| SECONDARY Change in Processing Speed |
0.03; 0.17 | — |
| SECONDARY Change in Memory |
0.03; -0.10 | — |
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.
Eligibility 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, 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.
Data sourced from ClinicalTrials.gov (NCT03306979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.