Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT07284693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phenolic Complex k110-42 Therapy on Cognitive Functions in Down Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-14', 'studyFirstSubmitDate': '2025-11-30', 'studyFirstSubmitQcDate': '2025-12-14', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive functions', 'timeFrame': 'At baseline before any intervention, at 3 month ,at 6 month', 'description': "Cognitive assessment will be assessed using Conners' Kiddie Continuous Performance Test (K-CPT)."}, {'measure': 'Cognitive assessment will be assessed using the Wechsler Intelligence Scale for Children-Fourth Edition.', 'timeFrame': 'At baseline before any intervention , at 3 month , at 6 month'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Functions']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the efficacy of phenolic complex k110-42 on cognitive function of children with Down syndrome', 'detailedDescription': '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.\n\nOne 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.\n\nSpecifically, 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 .\n\nPhenolic 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children diagnosed with Down syndrome (Non disjunction Trisomy 21) based on genetic testing .\n* Age between 4-8 years old .\n* Down syndrome children presented with difficulties in attention or focus as reported by parents or based on prior clinical assessments.\n\nExclusion Criteria:\n\n* Parents' refusal.\n* Down syndrome children with other significant developmental or neurological disorders (e.g., autism spectrum disorder, epilepsy).\n* 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.\n* Presence of hypersensitivity to spearmint or any components of Neumentix (Neumentix may increase kidney or liver damage if used in large amounts).\n* Use of stimulant ADHD medication or cognitive-enhancing supplements .\n* IQ test less than 55%.\n* Patients with hypothyroidism."}, 'identificationModule': {'nctId': 'NCT07284693', 'briefTitle': 'Phenolic Complex k110-42 Therapy on Cognitive Functions in Down Children', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Clinical Study Evaluating the Efficacy of Phenolic Complex k110-42 Therapy on Cognitive Functions of Children With Down Syndrome', 'orgStudyIdInfo': {'id': 'Ms.25.04.3157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Phenolic complex k110-42', 'description': '900mg/kg oral once sachet for 6 month', 'interventionNames': ['Drug: Phenolic complex k110-42']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Neumentix', 'description': 'Sachet once for 6 month', 'interventionNames': ['Drug: Neumentix']}], 'interventions': [{'name': 'Phenolic complex k110-42', 'type': 'DRUG', 'description': '900 mg/kg once oral in form of sachet for 6 month', 'armGroupLabels': ['Phenolic complex k110-42']}, {'name': 'Neumentix', 'type': 'DRUG', 'description': '0 mg/kg once sachet oral for 6 month', 'armGroupLabels': ['Neumentix']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Haidi Sameh Elassal, Master', 'role': 'CONTACT', 'email': 'Haydi.elassal@yahoo.com', 'phone': '0201061044831'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Haidi Sameh Ahmed Elassal', 'investigatorAffiliation': 'Mansoura University'}}}}