Brain FogPhase 4NBF-MG01NCT06695910
Modulation of the Brain Fog Scale by Eicosapentaenoic Acid Monoglycerides (MAG-EPA).
A Phase 4 study testing Monoglyceride Eicosapentaenoic acid (omega-3) and Sunflower Oil in people with Brain Fog and Cognitive Health, run by Samuel Fortin at 2 sites in Canada.
Trial summary
A growing body of studies shows that omega-3s act directly in molecular signaling pathways that reduce inflammation and are thought to have a positive effect on cognitive health. Brain fog is a term that has been popularized in the medical world in the wake of the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Fog, Cognitive Health
- What is being tested?
- Monoglyceride Eicosapentaenoic acid (omega-3) and Sunflower Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesCanada
- Study dates
- 6 Nov 2024to 1 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant between 19 and 55 years of age.
- Participant who reports having mental fatigue and/or frequent memory loss and/or difficulty concentrating and/or inattention, confusion and/or a feeling of decreased cognitive acuity for at least 28 days at the time of selection.
- Participant who obtains a mean score on the BFS screening questionnaires (BFS1 and BFS2) total of at least 30 and/OR who obtains the following minimum score on at least one of the three factors: Factor 1 of at least 15 and/or Factor 2 of at least 15 and/or Factor 3 of at least 12.
- Available for the entire duration of the study and willing to participate based on the information provided in the ICF duly read and signed by the latter.
- Absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements, ability to cooperate adequately, ability to understand and observe the instructions of the research staff.
- Participant having no difficulty in swallowing tablets, capsules or gelcaps.
Who cannot join
- Known allergy or intolerance to fish or history of allergic reactions attributable to fish, or to a compound similar to fish oil.
- Participant who has used omega-3 supplements in the 30 days preceding day 1 of the study.
- Pregnant or breastfeeding woman as declared by the latter.
- Presence of dependence on drugs of abuse or alcohol (˃ 3 units of alcohol per day, acute or chronic excessive consumption).
- Participant included in another clinical study and who is receiving an investigational product or other research treatment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Institut de recherche clinique du littoral (IRCL)
Maria, Quebec, G0C 1Y0
Anne-Julie Landry, Clinical Project Manager, M.Sc, DESS, 418-360-7480, ajlandry@ircl.ca
Ludger Blier, MD, MD
- Recruiting
Institut de recherche clinique du littoral (IRCL)
Rimouski, Quebec, G0K 1P0
Nancy Lemoignan, RN, ASN, nancylemoignan@hotmail.com
Ludger Blier, MD, MD
About this study
Official title: Modulation of the Brain Fog Scale by Eicosapentaenoic Acid Monoglycerides (MAG-EPA) in Volunteers Who Reported Suffering From Haze or Mental Fatigue on a Regular Basis. Exploratory Study (NBF-MG01).
A growing body of studies shows that omega-3s act directly in molecular signaling pathways that reduce inflammation and are thought to have a positive effect on cognitive health. Brain fog is a term that has been popularized in the medical world in the wake of the COVID-19 pandemic. A significant proportion of patients with long COVID reported having cognitive sequelae that were like fogginess. It is defined as a cognitive impairment with characteristic symptoms including problems with concentration, attention and memory, confusion, difficulty understanding what others are saying, reduced mental acuity and mental fatigue. These are episodes of reduced cognitive capacity that are not representative of the person's normal state. This condition can be caused by various factors such as stress, lack of sleep, overwork, depression, hormonal changes due to pregnancy or menopause in women, head injuries, migraine, certain diseases or viral infections, certain medications as well as substance abuse (alcohol and/or street drugs). In this study, we want to test whether omega-3 monoglycerides (MAG-EPA) can modulate the cognitive health of people with brain fog.
Read the detailed description
The study is divided into two phases. The first will include eight (8) subjects and all will receive the study treatment (MAG-EPA). This is a single arm phase. If signs of improvement in cognitive health are perceived in Phase 1, the study may continue with Phase 2.
Phase two will include forty (40) participants divided into two treatment groups. Assignment to any of the treatment groups will be done by randomization. This phase will be double-blind and controlled by placebo.
Participants will be asked to complete a Brain Fog Scale (BFS) questionnaire at Visit 0, immediately after signing the informed consent form. This questionnaire covers the 14 days preceding Visit 0. The subject will be asked to complete the BFS again at Visit 1, which should take place 14 days after Visit 0. These two questionnaires will provide a self-declared state of the participant's cognitive health in the 28 days preceding the start of treatment. The results of the first two questionnaires (BFS1 and BFS2) will determine whether the participant's cognitive state is severe enough to be eligible for participation in the study. Indeed, an exclusion criterion was written in the protocol to avoid including participants with normal cognitive health. Once enrolled in the study, subjects will be required to complete a BFS every 14 days until day 140, that is to say at each visit as well as at each telephone follow-up in between visits (V1, day 0; T1, day 14; V2, day 28; T2, day 42; V3, day 56; T3, day 70; V4, day 84; T4, day98; V5, day 112; T5, day 126 and V6, day 140).
Treatment will be given to each subject, MAG-EPA in phase 1 or either MAG-EPA or placebo (sunflower oil) in phase 2, to be taken daily from day 0 to day 112 (112 consecutive days in total, also corresponding to 16 weeks of treatment). Every subject will take 3 gelcaps daily for a total dose of 1.5g/day of MAG-EPA or 2.0g/day of sunflower oil. A wash-out period of 28 days, form day 112 to day 140, will follow treatment.
For research purposes, the Omega-3 Index will be measured from blood samples collected at Visit 1, 3, 5 and 6. The Omega-3 Index is a quantitative analysis that measures the blood level of Omega-3. This test is used both to confirm the adherence of subjects to treatment (for all subjects in Phase 1 as well as for the test group in Phase 2) and to control the restriction of Omega-3 in subjects in the control group (the placebo treatment in Phase 2). The Omega-3 Index results are indicative of the treatment received for each subject, therefore, the analysis reports will not be given to research staff who are blinded.
Demographic information will also be noted for every subject to better characterise the study population in each group.
Any adverse change to subject's health will be noted and followed until resolution or other final outcome.
- Conditions
- Brain Fog, Cognitive Health
- Being tested
- Monoglyceride Eicosapentaenoic acid (omega-3), Sunflower Oil
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monoglyceride Eicosapentaenoic acid (omega-3)Dietary supplement
Also called MAG-EPA
515 mg MAG-EPA + 33 mg MAG-DHA per capsule x 3 capsules daily: 1.5g/day (MAG-EPA). Subjects will be treated over a period of 56 days (or 112 days in phase 2) followed by a wash-out period of 28 days.
Sunflower OilOther
Also called Placebo
698 mg sunflower oil per capsule x 3 capsules: 2.0g/d sunflower oil (Placebo) Subjects will be treated over a period of 112 days followed by a wash-out period of 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Exploratory MAG-EPA treatment group | Experimental | This is a single arm phase of the study. Every subject will receive the experimental treatment (MAG-EPA) at 1,5g/day for a period of 8 weeks. Receives: Dietary Supplement: Monoglyceride Eicosapentaenoic acid (omega-3) |
| Phase 2: MAG-EPA treatment group | Experimental | This phase of the study is a parallel design. Subjects will be assigned to experimental treatment (MAG-EPA) by randomization. Every subject in this arm will receive the same treatment at 1,5g/day for a period of 16 weeks. Receives: Dietary Supplement: Monoglyceride Eicosapentaenoic acid (omega-3) |
| Phase 2: Placebo group | Placebo comparator | This phase of the study is a parallel design. Subjects will be assigned to Placebo treatment (sunflower oil) by randomization. Every subject will receive the same treatment at 2,0g/day for a period of 16 weeks. Receives: Other: Sunflower Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive health assessment with the Brain Fog Scale (BFS)
- Evaluate the brain fog of all subjects using the Brain Fog Scale (BFS) before the start of treatment, then every 14 days over a period of 98 days (BFS 1 to 8) in phase 1 or a period of 154 days in phase 2 (BFS 1 to 12).
- For each BFS measured after the start of treatment (BFS 3 to 8 in phase 1 or BFS 3 to 12 in phase 2), compare the score of each individual factor (Factor 1: mental fatigue; Factor 2: impaired cognitive acuity; Factor 3: confusion) with that obtained at the pre-treatment BFS measures (BFS 1 and 2).
- For each BFS measured after the start of treatment (BFS 3 to 8 in phase 1 or BFS 3 to 12 in phase 2), compare the total score with that obtained at the pre-treatment BFS measures (BFS 1 and 2).
Measured: Phase 1: Every two (2) weeks over a period of fourteen (14) weeks in total.Phase 2: Every two (2) weeks over a period of twenty-two (22) weeks in total.
Secondary outcomes (3)
Omega-3 intake assessment by Omega-3 index analysis
Measure the subjects' omega-3 index four times during the study (Day 0, Day 28, Day 56 and Day 84 in Phase 1; Day 0, Day 56, Day 112 and Day 140 in Phase 2) to validate if the level of omega-3 index correlates with BFS scores and that the subjects in the test group adhere to the treatment. This measurement is also used to check that subjects in the placebo group are not supplemented with omega-3 during the study. Blinded personnel and subjects will not have access to the results of omega-3 index testing.
Measured: At 0, 4, 8 and 12 weeks in phase 1; At 0, 8, 16 and 20 weeks after the start of the study in Phase 2.
Demographic data analysis
Demographic data such as age, gender, body mass index (BMI), substance use habits (alcohol, tobacco), sports habits, sleep habits as well as daily time spent using electronics will be collected to draw a detailed portrait of the studied population. These data will allow to correct for potential confounding variables in the event of an imbalance between the groups.
Measured: From week 0 to 12 in Phase 1; From week 0 to 20 in Phase 2.
Adverse Event reporting
Evaluate adverse events potentially related to MAG-EPA throughout the supplementation period as well as during the withdrawal period.
Measured: From week 2 to 12 in Phase 1; From week 2 to week 20 in Phase 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start6 Nov 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain FogStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is divided in two phases. Phase 1: Single arm. 8 subjects treated with MAG-EPA over a period of 56 days followed by a 28 days wash-out period. Phase 2: Two arms, placebo controlled, double-blind study. 40 subjects are assigned either to MAG-EPA or Placebo (sunflower oil) and are treated over a 112 days period followed by a 28 days wash-out period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samuel Fortin
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut de recherche clinique du littoral (IRCL)
- Responsible party
- Sponsor-investigator, Samuel Fortin, SCF Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695910
- Sponsor's protocol ID
- NBF-MG01
- Acronym
- NBF-MG01
- Status last verified
- Dec 2025
- First submitted
- 15 Nov 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing participant data require subject consent for sharing. We do not plan to recontact study subjects for data sharing consent.
Publications
Agata Debowska, Daniel Boduszek, Marek Ochman, Tomasz Hrapkowicz, Martyna Gaweda, Anastazja Pondel, Beata Horeczy, Brain Fog Scale (BFS): Scale development and validation, Personality and Individual Differences Volume 216, 2024, 112427, ISSN 0191-8869.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of the Brain Fog Scale by Eicosapentaenoic Acid Monoglycerides (MAG-EPA) in Volunteers Who Reported Suffering From Haze or Mental Fatigue on a Regular Basis. Exploratory Study (NBF-MG01).
- ClinicalTrials.gov ID
- NCT06695910
- Acronym / sponsor ID
- NBF-MG01 / NBF-MG01
- Conditions
- Brain Fog, Cognitive Health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Samuel FortinIndustry (pharma, biotech, devices)
- Collaborators
- Institut de recherche clinique du littoral (IRCL)
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A growing body of studies shows that omega-3s act directly in molecular signaling pathways that reduce inflammation and are thought to have a positive effect on cognitive health. Brain fog is a term that has been popularized in the medical world in the wake of the COVID-19 pandemic. A significant proportion of patients with long COVID reported having cognitive sequelae that were like fogginess. It is defined as a cognitive impairment with characteristic symptoms including problems with concentration, attention and memory, confusion, difficulty understanding what others are saying, reduced mental acuity and mental fatigue. These are episodes of reduced cognitive capacity that are not representative of the person's normal state. This condition can be caused by various factors such as stress, lack of sleep, overwork, depression, hormonal changes due to pregnancy or menopause in women, head injuries, migraine, certain diseases or viral infections, certain medications as well as substance abuse (alcohol and/or street drugs). In this study, we want to test whether omega-3 monoglycerides (MAG-EPA) can modulate the cognitive health of people with brain fog.
Detailed description
The study is divided into two phases. The first will include eight (8) subjects and all will receive the study treatment (MAG-EPA). This is a single arm phase. If signs of improvement in cognitive health are perceived in Phase 1, the study may continue with Phase 2.
Phase two will include forty (40) participants divided into two treatment groups. Assignment to any of the treatment groups will be done by randomization. This phase will be double-blind and controlled by placebo.
Participants will be asked to complete a Brain Fog Scale (BFS) questionnaire at Visit 0, immediately after signing the informed consent form. This questionnaire covers the 14 days preceding Visit 0. The subject will be asked to complete the BFS again at Visit 1, which should take place 14 days after Visit 0. These two questionnaires will provide a self-declared state of the participant's cognitive health in the 28 days preceding the start of treatment. The results of the first two questionnaires (BFS1 and BFS2) will determine whether the participant's cognitive state is severe enough to be eligible for participation in the study. Indeed, an exclusion criterion was written in the protocol to avoid including participants with normal cognitive health. Once enrolled in the study, subjects will be required to complete a BFS every 14 days until day 140, that is to say at each visit as well as at each telephone follow-up in between visits (V1, day 0; T1, day 14; V2, day 28; T2, day 42; V3, day 56; T3, day 70; V4, day 84; T4, day98; V5, day 112; T5, day 126 and V6, day 140).
Treatment will be given to each subject, MAG-EPA in phase 1 or either MAG-EPA or placebo (sunflower oil) in phase 2, to be taken daily from day 0 to day 112 (112 consecutive days in total, also corresponding to 16 weeks of treatment). Every subject will take 3 gelcaps daily for a total dose of 1.5g/day of MAG-EPA or 2.0g/day of sunflower oil. A wash-out period of 28 days, form day 112 to day 140, will follow treatment.
For research purposes, the Omega-3 Index will be measured from blood samples collected at Visit 1, 3, 5 and 6. The Omega-3 Index is a quantitative analysis that measures the blood level of Omega-3. This test is used both to confirm the adherence of subjects to treatment (for all subjects in Phase 1 as well as for the test group in Phase 2) and to control the restriction of Omega-3 in subjects in the control group (the placebo treatment in Phase 2). The Omega-3 Index results are indicative of the treatment received for each subject, therefore, the analysis reports will not be given to research staff who are blinded.
Demographic information will also be noted for every subject to better characterise the study population in each group.
Any adverse change to subject's health will be noted and followed until resolution or other final outcome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study is divided in two phases. Phase 1: Single arm. 8 subjects treated with MAG-EPA over a period of 56 days followed by a 28 days wash-out period. Phase 2: Two arms, placebo controlled, double-blind study. 40 subjects are assigned either to MAG-EPA or Placebo (sunflower oil) and are treated over a 112 days period followed by a 28 days wash-out period.
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Exploratory MAG-EPA treatment group | Experimental | Dietary Supplement: Monoglyceride Eicosapentaenoic acid (omega-3)This is a single arm phase of the study. Every subject will receive the experimental treatment (MAG-EPA) at 1,5g/day for a period of 8 weeks. |
| Phase 2: MAG-EPA treatment group | Experimental | Dietary Supplement: Monoglyceride Eicosapentaenoic acid (omega-3)This phase of the study is a parallel design. Subjects will be assigned to experimental treatment (MAG-EPA) by randomization. Every subject in this arm will receive the same treatment at 1,5g/day for a period of 16 weeks. |
| Phase 2: Placebo group | Placebo comparator | Other: Sunflower OilThis phase of the study is a parallel design. Subjects will be assigned to Placebo treatment (sunflower oil) by randomization. Every subject will receive the same treatment at 2,0g/day for a period of 16 weeks. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participant between 19 and 55 years of age.
- Participant who reports having mental fatigue and/or frequent memory loss and/or difficulty concentrating and/or inattention, confusion and/or a feeling of decreased cognitive acuity for at least 28 days at the time of selection.
- Participant who obtains a mean score on the BFS screening questionnaires (BFS1 and BFS2) total of at least 30 and/OR who obtains the following minimum score on at least one of the three factors: Factor 1 of at least 15 and/or Factor 2 of at least 15 and/or Factor 3 of at least 12.
- Available for the entire duration of the study and willing to participate based on the information provided in the ICF duly read and signed by the latter.
- Absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements, ability to cooperate adequately, ability to understand and observe the instructions of the research staff.
Key exclusion criteria (5 listed)
- Known allergy or intolerance to fish or history of allergic reactions attributable to fish, or to a compound similar to fish oil.
- Participant who has used omega-3 supplements in the 30 days preceding day 1 of the study.
- Pregnant or breastfeeding woman as declared by the latter.
- Presence of dependence on drugs of abuse or alcohol (˃ 3 units of alcohol per day, acute or chronic excessive consumption).
- Participant included in another clinical study and who is receiving an investigational product or other research treatment.
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 |
|---|---|---|
| Monoglyceride Eicosapentaenoic acid (omega-3)Also: MAG-EPA515 mg MAG-EPA + 33 mg MAG-DHA per capsule x 3 capsules daily: 1.5g/day (MAG-EPA). Subjects will be treated over a period of 56 days (or 112 days in phase 2) followed by a wash-out period of 28 days. | Dietary supplement | Phase 1: Exploratory MAG-EPA treatment group, Phase 2: MAG-EPA treatment group |
| Sunflower OilAlso: Placebo698 mg sunflower oil per capsule x 3 capsules: 2.0g/d sunflower oil (Placebo) Subjects will be treated over a period of 112 days followed by a wash-out period of 28 days. | Other | Phase 2: Placebo group |
Primary outcome
Cognitive health assessment with the Brain Fog Scale (BFS)
Time frame: Phase 1: Every two (2) weeks over a period of fourteen (14) weeks in total.Phase 2: Every two (2) weeks over a period of twenty-two (22) weeks in total.
* Evaluate the brain fog of all subjects using the Brain Fog Scale (BFS) before the start of treatment, then every 14 days over a period of 98 days (BFS 1 to 8) in phase 1 or a period of 154 days in phase 2 (BFS 1 to 12). * For each BFS measured after the start of treatment (BFS 3 to 8 in phase 1 or BFS 3 to 12 in phase 2), compare the score of each individual factor (Factor 1: mental fatigue; Factor 2: impaired cognitive acuity; Factor 3: confusion) with that obtained at the pre-treatment BFS measures (BFS 1 and 2). * For each BFS measured after the start of treatment (BFS 3 to 8 in phase 1 or BFS 3 to 12 in phase 2), compare the total score with that obtained at the pre-treatment BFS measures (BFS 1 and 2).
3 secondary outcomes
Omega-3 intake assessment by Omega-3 index analysis
Time frame: At 0, 4, 8 and 12 weeks in phase 1; At 0, 8, 16 and 20 weeks after the start of the study in Phase 2.
Demographic data analysis
Time frame: From week 0 to 12 in Phase 1; From week 0 to 20 in Phase 2.
Adverse Event reporting
Time frame: From week 2 to 12 in Phase 1; From week 2 to week 20 in Phase 2.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- BackgroundAgata Debowska, Daniel Boduszek, Marek Ochman, Tomasz Hrapkowicz, Martyna Gaweda, Anastazja Pondel, Beata Horeczy, Brain Fog Scale (BFS): Scale development and validation, Personality and Individual Differences Volume 216, 2024, 112427, ISSN 0191-8869.
- Individual participant dataSharing planned: No. Sharing participant data require subject consent for sharing. We do not plan to recontact study subjects for data sharing consent.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Monoglyceride Eicosapentaenoic acid (omega-3) and Sunflower Oil in people with Brain Fog and Cognitive Health, run by Samuel Fortin at 2 sites 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel Fortin, Investigator, Ph.D (1-418-750-8590, sfortin@scfpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive health assessment with the Brain Fog Scale (BFS) (time frame: Phase 1: Every two (2) weeks over a period of fourteen (14) weeks in total.Phase 2: Every two (2) weeks over a period of twenty-two (22) weeks in total.). 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 NCT06695910, 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 11 Dec 2025.