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Memory and Antioxidants in Vascular Impairment Trial

Primary Purpose

Vascular Cognitive Impairment no Dementia

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
N Acetylcysteine
Placebo oral capsule
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Cognitive Impairment no Dementia

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

N-acetylcysteine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 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

Change in processing speed
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.
Change in memory
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.

Full Information

First Posted
August 31, 2017
Last Updated
February 6, 2023
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03306979
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Cognitive Impairment no Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
N-acetylcysteine
Arm Type
Active Comparator
Arm Description
Participants randomized into the N-acetylcysteine arm will be receiving N-acetylcysteine for 24 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized into the placebo arm will be receiving placebo for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
N Acetylcysteine
Other Intervention Name(s)
NPN 80004844
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in executive function
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in processing speed
Description
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.
Time Frame
6 months
Title
Change in memory
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Krista L Lanctôt, PhD
Phone
416-480-6100
Ext
2241
Email
krista.lanctot@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krista L Lanctôt, PhD
Organizational Affiliation
Sunnybrook Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Ding
Phone
416-480-6100
Ext
63185
Email
jane.ding@sunnybrook.ca

12. IPD Sharing Statement

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Memory and Antioxidants in Vascular Impairment Trial

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