NCT07284693

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cognitive Functions

Interventions

Type	Name	Description
DRUG	Phenolic complex k110-42	900 mg/kg once oral in form of sachet for 6 month
DRUG	Neumentix	0 mg/kg once sachet oral for 6 month

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2025-12-16
• Last updated: 2025-12-16