Memory and Antioxidants in Vascular Impairment Trial

Phase 2

Completed

• Conditions: Vascular Cognitive Impairment no Dementia
• Interventions: Drug: N Acetylcysteine; Other: Placebo oral capsule

• Registration Number: NCT03306979
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-31
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-11
• Study Start: 2018-04-30
• Primary Completion: 2023-09-27
• Study Completion: 2023-09-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-acetylcysteine	N Acetylcysteine	Participants randomized into the N-acetylcysteine arm will be receiving N-acetylcysteine for 24 weeks.
Placebo	Placebo oral capsule	Participants randomized into the placebo arm will be receiving placebo for 24 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada