Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-01 @ 12:36 PM
Study NCT ID:
NCT06933095
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 153}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2024-12-04', 'studyFirstSubmitQcDate': '2025-04-10', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood glucose levels', 'timeFrame': 'Baseline, week 12, and week 24', 'description': 'Fasting blood glucose concentrations (mg/dL) as a measure of glucose regulation and insulin resistance.'}, {'measure': 'Blood insulin levels', 'timeFrame': 'Baseline, Week 12, week 24', 'description': 'Fasting blood insulin concentrations (pmol/L) as a measure of glucose homeostasis and insulin effectiveness.'}, {'measure': 'Blood triglycerides levels', 'timeFrame': 'Baseline, week 12, and week 24', 'description': 'Fasting blood triglycerides concentrations (mg/dL)'}, {'measure': 'Blood cholesterol levels', 'timeFrame': 'Baseline, week 12, and week 24', 'description': 'Fasting blood cholesterol concentrations (mg/dL)'}, {'measure': 'Blood alanine transaminase (ALT) levels', 'timeFrame': 'Baseline, week 12, and week 24', 'description': 'Fasting blood alanine transaminase concentrations (U/L) as a measure of liver function'}, {'measure': 'Blood aspartate aminotransferase (AST) levels', 'timeFrame': 'Baseline, week 12, and week 24', 'description': 'Fasting blood aspartate aminotransferase concentrations (U/L) as a measure of liver function'}, {'measure': 'Blood C-reactive protein (CRP) levels', 'timeFrame': 'Baseline, week 12, and week 24', 'description': 'Fasting blood C-reactive protein levels concentrations (mg/dL) as a measure of systemic inflammation'}], 'primaryOutcomes': [{'measure': 'CSF Docosahexaenoic acid (DHA) levels', 'timeFrame': 'From baseline through week 24', 'description': 'Baseline-Endpoint change in CSF docosahexaenoic acid (DHA) composition (g/100 g).'}], 'secondaryOutcomes': [{'measure': 'Amyloid-β1-42 (Aβ42)', 'timeFrame': 'Baseline through week 24', 'description': 'Baseline-Endpoint change in blood and CSF amyloid-β1-42 concentrations (ng/ml)'}, {'measure': 'Phospho-tau217 (p-tau217)', 'timeFrame': 'Baseline and Week 24', 'description': 'Baseline-Endpoint change in blood and CSF p-tau217 concentrations (ng/ml)'}, {'measure': 'Brain-derived neurotrophic factor (BDNF)', 'timeFrame': 'Baseline and Week 24', 'description': 'Baseline-Endpoint change in blood and CSF BDNF concentrations (ng/ml)'}, {'measure': 'Genotyping', 'timeFrame': 'Baseline', 'description': 'APOE alleles (ε2, ε3, ε4) allele frequency'}, {'measure': 'California Verbal Learning Test', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Objective assessment of episodic memory performance (Units on a scale) Scores range from 0 to 16 for individual learning trials, 0 to 80 for total words recalled across all trials, 0 to 16 for both short and long-delay free recall, and 0 to 16 for total hits. Higher scores indicate better performance on verbal memory'}, {'measure': 'Trail-Making Test, part B', 'timeFrame': 'Baseline, week 12, and week 24', 'description': 'Objective measure of speed of processing/executive functioning (Units on a scale). Scores range from 0 to 300 seconds to complete the task. Lower scores indicate better performance on executive function.'}, {'measure': 'Geriatric Depression Scale', 'timeFrame': 'Screening, Baseline, week 12, and week 24', 'description': 'Assessment of depression symptom severity (Units on a scale). The score range is from 0 to 15, with higher scores indicating more severe depression.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eldery People', 'Cognitive Decline', 'Memory Decline', 'DHA CNS Delivery']}, 'descriptionModule': {'briefSummary': 'The purpose of this placebo-controlled trial is to compare the effects of 24-weeks supplementation with LPC-DHA and TAG-DHA on cerebrospinal fluid and blood DHA levels, as well as biomarkers of central neurodegenerative and neurotrophic activity, in elderly adults experiencing early signs of cognitive/memory decline including those with mild cognitive impairment (MCI). Extant evidence supports our overarching hypothesis that LPC-DHA supplementation will be more effective than TAG-DHA for increasing central (CSF) DHA levels and improving biomarker profiles in elderly adults. To assess this hypothesis, the following aims are proposed:\n\nSPECIFIC AIM 1: To compare the effects of LPC-DHA and TAG-DHA supplementation on peripheral and CSF DHA levels in elderly adults experiencing early signs of cognitive/memory decline.\n\nSPECIFIC AIM 2: To compare the effects of LPC-DHA and TAG-DHA supplementation on neurotrophic and neurodegenerative biomarkers.\n\nSecondary Aim: To investigate whether changes in CSF DHA levels correlate with changes in objective measures of executive functioning and episodic memory performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. men and women 55 to 82 years old;\n2. presence of subjective cognitive decline or mild cognitive decline using the SCD questionnaire, DEX, EMQ, MoCA; and mCDR;\n3. No contraindication to a lumbar puncture (LP) unless opting to not have the LP (e.g., thrombocytopenia, coagulopathy, concomitant use of anticoagulant medications, etc.);\n4. fluency in English;\n5. ability to comprehend and comply with the research protocol; and\n6. provision of written informed consent.\n\nExclusion Criteria:\n\n1. diagnosis of dementia due to AD, Parkinson's disease, frontotemporal dementia, multi-infarct dementia, head trauma with loss of consciousness lasting more than 5 minutes and resulting in persisting functional decline within the three years prior to enrollment, epilepsy, leukoencephalopathy, other neurological conditions that would interfere the study objectives, mMIST \\<8 or MoCA-MI score \\<7;\n2. self-reported history of any psychotic disorder or bipolar disorder;\n3. diagnosis of atrial fibrillation, pancreatic, liver, kidney or hematological coagulation disorder;\n4. allergy to shellfish or seafood;\n5. current substance use causing physiological dependence or persisting change in functional capability;\n6. concomitant, regular use of medications that might affect primary outcome measures or adversely interact with the study product including anticoagulant medications;\n7. weekly fish consumption more than 1 x 3 oz servings and/or use of DHA-containing supplements within 3 months prior to screening."}, 'identificationModule': {'nctId': 'NCT06933095', 'briefTitle': 'Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia', 'orgStudyIdInfo': {'id': 'CNS DHA Delivery'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (mixture of olive oil, corn oil, palm oil)', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fish oil', 'description': 'Fish Oil', 'interventionNames': ['Dietary Supplement: LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)']}, {'type': 'EXPERIMENTAL', 'label': 'LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified t', 'description': 'LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)', 'interventionNames': ['Dietary Supplement: LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)']}], 'interventions': [{'name': 'LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'apsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)', 'armGroupLabels': ['LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified t', 'Placebo (mixture of olive oil, corn oil, palm oil)', 'fish oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karen Tugrul', 'role': 'CONTACT', 'email': 'tugrulkc@ucmail.uc.edu', 'phone': '513-558-6831'}, {'name': 'Dawn Skirpan', 'role': 'CONTACT', 'email': 'skirpadn@ucmail.uc.edu', 'phone': '513-558-8621'}], 'facility': 'University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Robert McNamara, PhD', 'role': 'CONTACT', 'email': 'mcnamar@ucmail.uc.edu', 'phone': '513-558-6831'}, {'name': 'Robert Krikorian, PhD', 'role': 'CONTACT', 'email': 'KRIKORR@UCMAIL.UC.EDU', 'phone': '513-558-6831'}], 'overallOfficials': [{'name': 'Robert McNamara, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Robert McNamara', 'investigatorAffiliation': 'University of Cincinnati'}}}}