Vascular Cognitive Impairment no DementiaPhase 2NCT03306979
Memory and Antioxidants in Vascular Impairment Trial
A Phase 2 study testing N Acetylcysteine in people with Vascular Cognitive Impairment no Dementia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Vascular Cognitive Impairment no Dementia
- What is being tested?
- N Acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 30 Apr 2018to 27 Sep 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of N-acetylcysteine (NAC) in Patients With Mild Vascular Cognitive Impairment
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.
- Being tested
- N Acetylcysteine, Placebo oral capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N AcetylcysteineDrug
Also called NPN 80004844
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.
Placebo oral capsuleOther
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Active comparator | Participants randomized into the N-acetylcysteine arm will be receiving N-acetylcysteine for 24 weeks. Receives: Drug: N Acetylcysteine |
| Placebo | Placebo comparator | Participants randomized into the placebo arm will be receiving placebo for 24 weeks. Receives: Other: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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 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. Higher z-score represents better cognitive function.
Measured: 6 months
Change in Memory
Differences in memory composite z scores between experimental and placebo groups at 6 months. Memory will be based on the Hopkins Verbal Learning Test 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. Higher z-scores represent better cognitive function.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start30 Apr 2018
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular Cognitive Impairment no DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krista L Lanctôt, PhD, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306979
- Sponsor's protocol ID
- 241-2017
- Status last verified
- Mar 2024
- First submitted
- 31 Aug 2017
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gallagher D, Kang Y, Herrmann N, Kiss A, Black SE, Oh P, Marzolini S, Rabin JS, Andreazza A, Ramirez J, Gao F, Rapoport M, Chen JJ, Survilla K, Vieira D, Mah E, Swardfager W, Lanctot KL. Efficacy and safety of N-acetylcysteine in patients with mild cognitive impairment undergoing exercise-based cardiac rehabilitation program: a randomized controlled trial. Alzheimers Res Ther. 2026 Apr 27;18(1):144. doi: 10.1186/s13195-026-02062-z.
PubMed 42045982
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of N-acetylcysteine (NAC) in Patients With Mild Vascular Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03306979
- Acronym / sponsor ID
- 241-2017
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Posted 26 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Active comparator | Drug: N AcetylcysteineParticipants randomized into the N-acetylcysteine arm will be receiving N-acetylcysteine for 24 weeks. |
| Placebo | Placebo comparator | Other: Placebo oral capsuleParticipants randomized into the placebo arm will be receiving placebo for 24 weeks. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N AcetylcysteineAlso: NPN 80004844Patients 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. | Drug | N-acetylcysteine |
| Placebo oral capsuleAlso: PlaceboPatients 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 | Placebo |
Primary outcome
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, 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.
2 secondary outcomes
Change in Processing Speed
Time frame: 6 months
Change in Memory
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42045982Gallagher D, Kang Y, Herrmann N, Kiss A, Black SE, Oh P, Marzolini S, Rabin JS, Andreazza A, Ramirez J, Gao F, Rapoport M, Chen JJ, Survilla K, Vieira D, Mah E, Swardfager W, Lanctot KL. Efficacy and safety of N-acetylcysteine in patients with mild cognitive impairment undergoing exercise-based cardiac rehabilitation program: a randomized controlled trial. Alzheimers Res Ther. 2026 Apr 27;18(1):144. doi: 10.1186/s13195-026-02062-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krista L Lanctôt, PhD principal investigator
Sunnybrook Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N Acetylcysteine in people with Vascular Cognitive Impairment no Dementia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Executive Function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03306979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.