Memory and Antioxidants in Vascular Impairment Trial

NCT03306979 | Completed Phase 2 Results

• 1 other identifier: 241-2017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Cognitive Impairment no Dementia

Outcome Measures

Primary Outcomes (1)

• Change in Executive Function

  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, phonemic fluency, and semantic fluency found in the 60-minute battery recommended by the National Institute of Neurological Disorders and Stroke-Canadian Stroke Network (NINDS-CSN) harmonized standards. A Z-score was computed based on published age-matched norms, and a composite Z-score was calculated. Higher z score represents better cognitive function.

  6 months

Secondary Outcomes (2)

• Change in Processing Speed

  6 months

• Change in Memory

  6 months

Study Arms (2)

N-acetylcysteine

ACTIVE COMPARATOR

Participants randomized into the N-acetylcysteine arm will be receiving N-acetylcysteine for 24 weeks.

Drug: N Acetylcysteine

Placebo

PLACEBO COMPARATOR

Participants randomized into the placebo arm will be receiving placebo for 24 weeks.

Other: Placebo oral capsule

Interventions

N Acetylcysteine DRUG

Patients will be randomized to receive N Acetylcysteine (NAC) (four 600 mg capsules given as 2 capsules in the morning and 2 capsules in the evening). 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.

Also known as: NPN 80004844

N-acetylcysteine

Placebo oral capsule OTHER

Patients will receive four placebo capsules (lactose-based filler) given as 2 capsules in the morning and 2 capsules in the evening, which will be prepared to mimic the weight of the experimental capsules.The initial placebo 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.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Krista Lanctôt, Senior Scientist
• Organization: Sunnybrook Health Sciences Centre

krista.lanctot@sunnybrook.ca

416-480-6100

Study Officials

• Krista L Lanctôt, PhD

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: October 11, 2017
• Study Start: April 30, 2018
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2024-03

Locations

CA (1)