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

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• Cognitive functions [Time frame: 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. [Time frame: At baseline before any intervention , at 3 month , at 6 month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07284693 · Ms.25.04.3157

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗