Trial Outcomes & Findings for Memory and Antioxidants in Vascular Impairment Trial (NCT NCT03306979)
NCT ID: NCT03306979
Last Updated: 2025-03-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
6 months
Results posted on
2025-03-26
Participant Flow
Participant milestones
| Measure |
N-acetylcysteine
Participants randomized into the N-acetylcysteine arm will be receiving N-acetylcysteine for 24 weeks.
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.
|
Placebo
Participants randomized into the placebo arm will be receiving placebo for 24 weeks.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Memory and Antioxidants in Vascular Impairment Trial
Baseline characteristics by cohort
| Measure |
N-acetylcysteine
n=29 Participants
Participants randomized into the N-acetylcysteine arm will be receiving N-acetylcysteine for 24 weeks.
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.
|
Placebo
n=30 Participants
Participants randomized into the placebo arm will be receiving placebo for 24 weeks.
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.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
68.0 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
67.6 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Arab/Middle Eastern
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian/South Asian
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black/African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Caucasian/European
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other (mixed)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Executive Function
|
-0.54 z-score
STANDARD_DEVIATION 0.68 • n=5 Participants
|
-0.48 z-score
STANDARD_DEVIATION 0.48 • n=7 Participants
|
-0.52 z-score
STANDARD_DEVIATION 0.58 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsDifferences 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.
Outcome measures
| Measure |
N-acetylcysteine
n=29 Participants
Participants randomized into the N-acetylcysteine arm will be receiving N-acetylcysteine for 24 weeks.
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.
|
Placebo
n=30 Participants
Participants randomized into the placebo arm will be receiving placebo for 24 weeks.
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.
|
|---|---|---|
|
Change in Executive Function
|
0.32 z-score
Interval 0.2 to 0.52
|
0.36 z-score
Interval 0.2 to 0.52
|
SECONDARY outcome
Timeframe: 6 monthsDifferences 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.
Outcome measures
| Measure |
N-acetylcysteine
n=29 Participants
Participants randomized into the N-acetylcysteine arm will be receiving N-acetylcysteine for 24 weeks.
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.
|
Placebo
n=30 Participants
Participants randomized into the placebo arm will be receiving placebo for 24 weeks.
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.
|
|---|---|---|
|
Change in Processing Speed
|
0.03 Z-score
Interval -0.16 to 0.35
|
0.17 Z-score
Interval -0.02 to 0.35
|
SECONDARY outcome
Timeframe: 6 monthsDifferences 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.
Outcome measures
| Measure |
N-acetylcysteine
n=29 Participants
Participants randomized into the N-acetylcysteine arm will be receiving N-acetylcysteine for 24 weeks.
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.
|
Placebo
n=30 Participants
Participants randomized into the placebo arm will be receiving placebo for 24 weeks.
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.
|
|---|---|---|
|
Change in Memory
|
0.03 z-score
Interval -0.21 to 0.27
|
-0.10 z-score
Interval -0.21 to 0.19
|
Adverse Events
N-acetylcysteine
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
N-acetylcysteine
n=29 participants at risk
Participants randomized into the N-acetylcysteine arm will be receiving N-acetylcysteine for 24 weeks.
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.
|
Placebo
n=30 participants at risk
Participants randomized into the placebo arm will be receiving placebo for 24 weeks.
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.
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
34.5%
10/29 • 6 months
|
20.0%
6/30 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
6.9%
2/29 • 6 months
|
16.7%
5/30 • 6 months
|
|
General disorders
Headache
|
27.6%
8/29 • 6 months
|
16.7%
5/30 • 6 months
|
|
Gastrointestinal disorders
Epigastric discomfort
|
31.0%
9/29 • 6 months
|
23.3%
7/30 • 6 months
|
|
General disorders
Nausea
|
17.2%
5/29 • 6 months
|
0.00%
0/30 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.3%
3/29 • 6 months
|
6.7%
2/30 • 6 months
|
|
Ear and labyrinth disorders
Tinnitus
|
13.8%
4/29 • 6 months
|
6.7%
2/30 • 6 months
|
Additional Information
Dr. Krista Lanctôt, Senior Scientist
Sunnybrook Health Sciences Centre
Phone: 416-480-6100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place