60 Participants Needed

N Acetylcysteine for Cognitive Impairment

KL
Overseen ByKrista L Lanctôt, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sunnybrook Health Sciences Centre
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial tests if taking an NAC supplement can help improve brain function in patients with mild cognitive issues who are also in a heart rehab program. NAC works by protecting brain cells from damage. N-acetylcysteine (NAC) has been studied for its potential benefits in various conditions, including brain injury, cognitive impairment, and oxidative stress.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you use daily Nitroglycerin, you cannot participate in the trial.

What evidence supports the effectiveness of the drug N Acetylcysteine for cognitive impairment?

Research on N-acetylcysteine (NAC) for Alzheimer's disease showed that it helped improve some cognitive tasks, suggesting it might be beneficial for cognitive impairment. Additionally, studies on other cognition enhancers like piracetam have shown improvements in memory, which might indicate potential benefits of similar treatments.12345

Is N-acetylcysteine safe for human use?

N-acetylcysteine (NAC) has been studied in patients with Alzheimer's disease and is generally considered safe, with no significant safety concerns reported in the study.16789

How does the drug N-acetylcysteine differ from other treatments for cognitive impairment?

N-acetylcysteine is unique because it may help increase levels of glutathione, an important antioxidant, which could reduce oxidative stress linked to cognitive decline. Unlike other treatments, it is also available as a dietary supplement and has potential neuroprotective benefits, although its low bioavailability is a challenge.1011121314

Research Team

KL

Krista L Lanctôt, PhD

Principal Investigator

Sunnybrook Research Institute

Eligibility Criteria

Inclusion Criteria

Males or females aged 55-80 years.
Speaks and understands English.
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.
See 2 more

Exclusion Criteria

You have had a stroke in the past.
You have extremely high or low blood pressure, as determined by a doctor.
You have a current neurological condition such as Parkinson's disease, multiple sclerosis, or significant traumatic brain injury.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral NAC supplementation as an add-on therapy to improve cognitive function, with dosage increasing weekly until reaching 2,400 mg/day, alongside a cardiac rehabilitation program

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • N Acetylcysteine
  • Placebo oral capsule
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: N-acetylcysteineActive Control1 Intervention
Participants randomized into the N-acetylcysteine arm will be receiving N-acetylcysteine for 24 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized into the placebo arm will be receiving placebo for 24 weeks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials
693
Recruited
1,569,000+

Findings from Research

In a double-blind study involving patients with probable Alzheimer's disease, N-acetylcysteine (NAC) was administered and showed favorable effects on cognitive outcomes compared to placebo after 3 and 6 months of treatment.
While NAC treatment improved nearly all measured outcomes, significant differences were only observed in a subset of cognitive tasks, suggesting potential benefits that may vary across different cognitive functions.
Controlled trial of N-acetylcysteine for patients with probable Alzheimer's disease.Adair, JC., Knoefel, JE., Morgan, N.[2019]
In a study of 162 patients with age-associated memory impairment, a combination of piracetam (4.8 g) and cognitive therapy showed the most significant improvement in memory, particularly in those with the lowest baseline performance.
The optimal results were achieved when cognitive training sessions started after 6 weeks of piracetam treatment, indicating a potential timing effect in the intervention's efficacy.
Drug therapy and memory training programs: a double-blind randomized trial of general practice patients with age-associated memory impairment.Israel, L., Melac, M., Milinkevitch, D., et al.[2019]
In a review of placebo group data from multiple trials for mild cognitive impairment (MCI), significant variability in performance was observed, with NIA trials showing expected cognitive decline while industry-sponsored trials often reported stable or improved performance.
The presence of the APOE4 gene variant influenced cognitive outcomes, indicating that genetic factors may play a role in how participants respond in MCI trials, despite similar diagnostic criteria being used across studies.
Randomized controlled trials in mild cognitive impairment: Sources of variability.Petersen, RC., Thomas, RG., Aisen, PS., et al.[2022]

References

Controlled trial of N-acetylcysteine for patients with probable Alzheimer's disease. [2019]
Drug therapy and memory training programs: a double-blind randomized trial of general practice patients with age-associated memory impairment. [2019]
Expectancy effect: impact of pill administration on cognitive performance in healthy seniors. [2019]
Efficacy and clinical relevance of cognition enhancers. [2019]
Randomized controlled trials in mild cognitive impairment: Sources of variability. [2022]
Five Unapproved Drugs Found in Cognitive Enhancement Supplements. [2022]
Substances used and prevalence rates of pharmacological cognitive enhancement among healthy subjects. [2014]
Oral intake of carboxy alkyl ester improves attention: A randomized double-blind cross-over placebo-controlled study. [2023]
The Use and Impact of Cognitive Enhancers among University Students: A Systematic Review. [2023]
Clinical pharmacokinetics of N-acetylcysteine. [2022]
Analysis of the dose-response of N-acetylcysteine in the prevention of sensory neuronal loss after peripheral nerve injury. [2019]
Dose dependent pharmacokinetics of N-acetylcysteine after oral dosing to man. [2019]
Evaluation of the Neuroprotective Potential of N-Acetylcysteine for Prevention and Treatment of Cognitive Aging and Dementia. [2018]
14.United Statespubmed.ncbi.nlm.nih.gov
Intravenous Administration of Stable-Labeled N-Acetylcysteine Demonstrates an Indirect Mechanism for Boosting Glutathione and Improving Redox Status. [2015]