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Memory and Antioxidants in Vascular Impairment Trial

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ClinicalTrials.gov Identifier: NCT03306979
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : February 28, 2022
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vascular Cognitive Impairment no Dementia Drug: N Acetylcysteine Other: Placebo oral capsule Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of N-acetylcysteine (NAC) in Patients With Mild Vascular Cognitive Impairment
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: N-acetylcysteine
Participants randomized into the N-acetylcysteine arm will be receiving N-acetylcysteine for 24 weeks.
 Drug: N Acetylcysteine
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.
Other Name: NPN 80004844
Placebo Comparator: Placebo
Participants randomized into the placebo arm will be receiving placebo for 24 weeks.
 Other: Placebo oral capsule
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.
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change in executive function [ Time Frame: 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 :
  1. Change in processing speed [ Time Frame: 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.

  2. Change in memory [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306979


Contacts
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Contact: Krista L Lanctôt, PhD 416-480-6100 ext 2241 krista.lanctot@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Jane Ding    416-480-6100 ext 63185    jane.ding@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Krista L Lanctôt, PhD Sunnybrook Research Institute
More Information
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03306979    
Other Study ID Numbers: 241-2017
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: February 28, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
 Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes