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NCT Number: NCT07284693

Phenolic Complex k110-42 Therapy on Cognitive Functions in Down Children

The goal of this study is to evaluate the efficacy of phenolic complex k110-42 on cognitive function of children with Down syndrome

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Key information

Conditions

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Phenolic complex k110-42

Drug

900 mg/kg once oral in form of sachet for 6 month

Neumentix

Drug

0 mg/kg once sachet oral for 6 month

Primary outcomes

  1. 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).

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Haidi Sameh Elassal, Master

CONTACT

[email protected]

0201061044831

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Clinical Study Evaluating the Efficacy of Phenolic Complex k110-42 Therapy on Cognitive Functions of Children With Down Syndrome

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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