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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Functions
• Intervention / Treatment: Drug: Phenolic complex k110-42; Drug: Neumentix

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 Type: Interventional
• Enrollment (Estimated): 108
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Haidi Sameh Elassal, Master; Phone Number: 0201061044831; Email: Haydi.elassal@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Phenolic complex k110-42; 900mg/kg oral once sachet for 6 month	Drug: Phenolic complex k110-42; 900 mg/kg once oral in form of sachet for 6 month
Placebo Comparator: Neumentix; Sachet once for 6 month	Drug: Neumentix; 0 mg/kg once sachet oral for 6 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive functions	Cognitive assessment will be assessed using Conners' Kiddie Continuous Performance Test (K-CPT).	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.		At baseline before any intervention , at 3 month , at 6 month

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 30, 2025
• First Submitted That Met QC Criteria: December 14, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Ms.25.04.3157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No