NCT06695910 Modulation of the Brain Fog Scale by Eicosapentaenoic Acid Monoglycerides (MAG-EPA).
| NCT ID | NCT06695910 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Samuel Fortin |
| Condition | Brain Fog |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-11-06 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 48 participants in total. It began in 2024-11-06 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 1. Participant between 19 and 55 years of age. 2. 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. 3. 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. 4. 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. 5. 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. 6. Participant having no difficulty in swallowing tablets, capsules or gelcaps. Exclusion Criteria: 1. Known allergy or intolerance to fish or history of allergic reactions attributable to fish, or to a compound similar to fish oil. 2. Participant who has used omega-3 supplements in the 30 days preceding day 1 of the study. 3. Pregnant or breastfeeding woman as declared by the latter. 4. Presence of dependence on drugs of abuse or alcohol (˃ 3 units of alcohol per day, acute or chronic excessive consumption). 5. Participant included in another clinical study and who is receiving an investigational product or other research treatment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06695910 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 55 Years, studying Brain Fog. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06695910 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06695910 currently recruiting?
Yes, NCT06695910 is actively recruiting participants. Contact the research team at sfortin@scfpharma.com for enrollment information.
Where is the NCT06695910 trial being conducted?
This trial is being conducted at Maria, Canada, Rimouski, Canada.
Who is sponsoring the NCT06695910 clinical trial?
NCT06695910 is sponsored by Samuel Fortin. The trial plans to enroll 48 participants.