Status:
COMPLETED
Memory and Antioxidants in Vascular Impairment Trial
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Vascular Cognitive Impairment no Dementia
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03306979
Start Date
April 30 2018
End Date
September 27 2023
Last Update
March 26 2025
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5