Clinical trial NCT03306979: Memory and Antioxidants in Vascular Impairment Trial
Official title: Efficacy and Safety of N-acetylcysteine (NAC) in Patients With Mild Vascular Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vascular Cognitive Impairment no Dementia
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Executive Function
timeFrame: 6 months
Secondary outcomes:
measure: Change in Processing Speed
timeFrame: 6 months
measure: Change in Memory
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Research Institute
name: Krista L Lanctôt, PhD
role: PRINCIPAL_INVESTIGATOR
References: