Cognitive FunctionsPhase 3NCT07284693
Phenolic Complex k110-42 Therapy on Cognitive Functions in Down Children
A Phase 3 study testing Phenolic complex k110-42 and Neumentix in people with Cognitive Functions, run by Mansoura University.
Trial summary
The goal of this study is to evaluate the efficacy of phenolic complex k110-42 on cognitive function of children with Down syndrome Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Cognitive Functions
- What is being tested?
- Phenolic complex k110-42 and Neumentix
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2026
- Phase
- Phase 3
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with Down syndrome (Non disjunction Trisomy 21) based on genetic testing .
- Age between 4-8 years old .
- Down syndrome children presented with difficulties in attention or focus as reported by parents or based on prior clinical assessments.
Who cannot join
- Parents' refusal.
- Down syndrome children with other significant developmental or neurological disorders (e.g., autism spectrum disorder, epilepsy).
- Patients with any chronic illness as liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event, eating disorders (anorexia, bulimia) or gastrointestinal disorders.
- Presence of hypersensitivity to spearmint or any components of Neumentix (Neumentix may increase kidney or liver damage if used in large amounts).
- Use of stimulant ADHD medication or cognitive-enhancing supplements .
- IQ test less than 55%.
- Patients with hypothyroidism.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study Evaluating the Efficacy of Phenolic Complex k110-42 Therapy on Cognitive Functions of Children With Down Syndrome
The goal of this study is to evaluate the efficacy of phenolic complex k110-42 on cognitive function of children with Down syndrome
Read the detailed description
Children with Down syndrome (DS) often face a variety of cognitive and developmental challenges. These challenges may include delays in speech, motor skills, and social-emotional development. Among these, difficulties with attention and focus are particularly prominent, making it harder for children with DS to participate in academic and everyday activities.
One promising avenue for improving cognitive function is the use of natural compounds with neuroprotective and cognitive-enhancing properties. The phenolic complex K110-42 (Neumentix), derived from the extract of spearmint, has garnered attention for its potential benefits in cognitive performance.
Specifically, polyphenols contained within the aqueous extracts from the Lamiaceae family could mechanistically account for the reported benefits on cognitive performance. Polyphenols found in aqueous extracts of spearmint such as salvianolic and rosmarinic acids have been shown to have anti-oxidant, anti-inflammatory, anti-acetylcholinesterase, and neuroprotective biological activity both in vitro and in vivo .
Phenolic offers a number of benefits on cognitive functions and it is plausible that its anti-inflammatory, antioxidant, anti-fibrotic effects, enhance attention, improving vascular endothelial functions and enhancement of metabolic performances. Because of the multiple functions, phenolic has direct effects on attention deficit in DS.
- Conditions
- Cognitive Functions
- Being tested
- Phenolic complex k110-42, Neumentix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenolic complex k110-42Drug
900 mg/kg once oral in form of sachet for 6 month
NeumentixDrug
0 mg/kg once sachet oral for 6 month
| Study group | Role | What they receive |
|---|---|---|
| Phenolic complex k110-42 | Active comparator | 900mg/kg oral once sachet for 6 month Receives: Drug: Phenolic complex k110-42 |
| Neumentix | Placebo comparator | Sachet once for 6 month Receives: Drug: Neumentix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive functions
Cognitive assessment will be assessed using Conners' Kiddie Continuous Performance Test (K-CPT).
Measured: At baseline before any intervention, at 3 month ,at 6 month
Cognitive assessment will be assessed using the Wechsler Intelligence Scale for Children-Fourth Edition.
Measured: At baseline before any intervention , at 3 month , at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionsStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haidi Sameh Ahmed Elassal, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284693
- Sponsor's protocol ID
- Ms.25.04.3157
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Efficacy of Phenolic Complex k110-42 Therapy on Cognitive Functions of Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT07284693
- Acronym / sponsor ID
- Ms.25.04.3157
- Conditions
- Cognitive Functions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Dec 2025 (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.
The goal of this study is to evaluate the efficacy of phenolic complex k110-42 on cognitive function of children with Down syndrome
Detailed description
Children with Down syndrome (DS) often face a variety of cognitive and developmental challenges. These challenges may include delays in speech, motor skills, and social-emotional development. Among these, difficulties with attention and focus are particularly prominent, making it harder for children with DS to participate in academic and everyday activities.
One promising avenue for improving cognitive function is the use of natural compounds with neuroprotective and cognitive-enhancing properties. The phenolic complex K110-42 (Neumentix), derived from the extract of spearmint, has garnered attention for its potential benefits in cognitive performance.
Specifically, polyphenols contained within the aqueous extracts from the Lamiaceae family could mechanistically account for the reported benefits on cognitive performance. Polyphenols found in aqueous extracts of spearmint such as salvianolic and rosmarinic acids have been shown to have anti-oxidant, anti-inflammatory, anti-acetylcholinesterase, and neuroprotective biological activity both in vitro and in vivo .
Phenolic offers a number of benefits on cognitive functions and it is plausible that its anti-inflammatory, antioxidant, anti-fibrotic effects, enhance attention, improving vascular endothelial functions and enhancement of metabolic performances. Because of the multiple functions, phenolic has direct effects on attention deficit in DS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenolic complex k110-42 | Active comparator | Drug: Phenolic complex k110-42900mg/kg oral once sachet for 6 month |
| Neumentix | Placebo comparator | Drug: NeumentixSachet once for 6 month |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children diagnosed with Down syndrome (Non disjunction Trisomy 21) based on genetic testing .
- Age between 4-8 years old .
- Down syndrome children presented with difficulties in attention or focus as reported by parents or based on prior clinical assessments.
Key exclusion criteria (7 listed)
- Parents' refusal.
- Down syndrome children with other significant developmental or neurological disorders (e.g., autism spectrum disorder, epilepsy).
- Patients with any chronic illness as liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event, eating disorders (anorexia, bulimia) or gastrointestinal disorders.
- Presence of hypersensitivity to spearmint or any components of Neumentix (Neumentix may increase kidney or liver damage if used in large amounts).
- Use of stimulant ADHD medication or cognitive-enhancing supplements .
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 |
|---|---|---|
| Phenolic complex k110-42900 mg/kg once oral in form of sachet for 6 month | Drug | Phenolic complex k110-42 |
| Neumentix0 mg/kg once sachet oral for 6 month | Drug | Neumentix |
Primary outcome
Cognitive functions
Time frame: At baseline before any intervention, at 3 month ,at 6 month
Cognitive assessment will be assessed using Conners' Kiddie Continuous Performance Test (K-CPT).
Cognitive assessment will be assessed using the Wechsler Intelligence Scale for Children-Fourth Edition.
Time frame: At baseline before any intervention , at 3 month , at 6 month
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 16 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phenolic complex k110-42 and Neumentix in people with Cognitive Functions, run by Mansoura University.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Haidi Sameh Elassal, Master (0201061044831, Haydi.elassal@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive functions (time frame: At baseline before any intervention, at 3 month ,at 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2025.