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

NCT07284693 | Not Yet Recruiting Phase 3

• 1 other identifier: Ms.25.04.3157
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cognitive Functions

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Phenolic complex k110-42

ACTIVE COMPARATOR

900mg/kg oral once sachet for 6 month

Drug: Phenolic complex k110-42

Neumentix

PLACEBO COMPARATOR

Sachet once for 6 month

Drug: Neumentix

Interventions

Phenolic complex k110-42 DRUG

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

Phenolic complex k110-42

Neumentix DRUG

0 mg/kg once sachet oral for 6 month

Neumentix

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Central Study Contacts

Haidi Sameh Elassal, Master

CONTACT

0201061044831; Haydi.elassal@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 16, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share