Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-28 @ 9:13 PM
Study NCT ID:
NCT07000734
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069439', 'term': 'Dasatinib'}, {'id': 'D011794', 'term': 'Quercetin'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D000078784', 'term': 'Vortioxetine'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D044948', 'term': 'Flavonols'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-05-29', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Motor function', 'timeFrame': '5 months', 'description': 'Endurance capacity; 6 Minute Walking Test Lower body power: Leg dynamometer Skeletal muscle: D3 creatine dilution'}, {'measure': 'Cognitive Function', 'timeFrame': '5 months', 'description': 'NIH Toolbox Cognitive Battery, Fluid Cognition Composite. Each of the 5 subscales have a mean of 100 with a standard deviation of 15.'}, {'measure': 'Immune Function', 'timeFrame': '5 months', 'description': 'Blood draws to look at biomarkers related to immune function'}], 'primaryOutcomes': [{'measure': 'Number of participants who completed the outcome measure assessments and intervention', 'timeFrame': '5 months', 'description': 'Reviewing feasibility outcomes including recruitment, retention, participant adherence, interventionist fidelity to behavioral treament protocols and collection of outcome measures.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging', 'Cognitive Decline', 'Older Adults', 'Cardiovascular', 'Sedentary Behaviors', 'Immune Senescence', 'Motor Function']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to explore ways to improve motor, cognitive and immune functions for aging adults using multiple techniques like lifestyle changes and risk factor management, as well as medications and supplements believed to have a positive effect on health.', 'detailedDescription': 'The goal in this pilot open-label study is to conduct a feasibility test of a multi-component, personalized intervention designed to improve the aging human healthspan. The trial will recruit at least 20 adults aged 50-70, both male and female. The total time of study participation is up to 5 months.\n\nThe intervention will last for approximately 3 months, with testing of motor, cognitive, and immune outcomes before and after the intervention.\n\nThe intervention consist of three components:\n\n1. Fortify Healthy Behaviors: behavioral lifestyle management that combines an exercise program, healthy eating behaviors and optimizing sleep quality;\n2. Optimize Medical Therapies: reviewing the participants cardiovascular risk factors, smoking cessation when indicated, treatment with the senolytic medication dasatinib combined with the antioxidant quercetin , and dietary supplements relevant for brain, bone and immune system functioning; and\n3. Enhance Cognitive Function: vortioxetine (an antidepressant shown to have pro-cognitive properties), in combination with digital cognitive training to improve fluid cognition and memory, and deprescribing of drugs with CNS toxicity (i.e. those that cause cognitive difficulties).\n\nThe outcome assessments will be measured both pre- and post-intervention and up to three times at each time point. These assessments will look at biomarkers related to aging. Assessments will include strength and endurance tests, validated neuropsychological tests, and a blood drawn to look at immune function.\n\nAn MRI scan will also be offered to participants who are able to undergo the scan to look at brain health and aging, both pre- and post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Participants must be residents of Illinois or Missouri and able to come to St. Louis offices in person.\n\nInclusion Criteria:\n\n* Ages 50-70\n* Able to come to the research center for testing and intervention visits.\n* Sedentary (no moderate exercise and no more than 15-minutes per day of light exercise (confirmed via interview with participants)).\n* BMI≥27 or Body Roundness index ≥6\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Dementia or other clinical neurodegenerative illness (e.g., Parkinson's disease, cerebrovascular disease unless minor eg one lacunar infarct with minimal/no impairment) per self-report or medical records.\n* Medical conditions that suggest shortened lifespan (such as metastatic cancer), severe/uncontrolled psychiatric disorders or conditions that would prohibit safe participation.\n* Unable to perform study assessments.\n* Alcohol or substance abuse within 6 months per self-report or medical records.\n* Concurrent cognitive training, such as brain-training software, or other interventions expected to affect neuroplasticity.\n* Any drug that interacts pharmacokinetically, or is contraindicated with study interventions (examples would include high-dose SSRI that should not be combined with vortioxetine)\n* PI has discretion to exclude potential participants eg if their health status appears either too good or too poor to be amenable to intervention"}, 'identificationModule': {'nctId': 'NCT07000734', 'acronym': 'FOES', 'briefTitle': 'Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study', 'orgStudyIdInfo': {'id': '202503023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine', 'description': 'Open label multicomponent, personalized intervention incorporating behavioral and medicinal therapies', 'interventionNames': ['Behavioral: Risk managment', 'Drug: Dasatinib', 'Dietary Supplement: Quercetin (dietary supplement)', 'Drug: Vortioxetine']}], 'interventions': [{'name': 'Risk managment', 'type': 'BEHAVIORAL', 'description': 'Behavioral lifestyle changes including an exercise program, healthy eating recommendations, reviewing medical management for cardiometabolic risk conditions, deprescribing review for brain toxic meds, online cognitive training, as well as recommendations to improve sleep quality, or smoking cessation as needed', 'armGroupLabels': ['Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine']}, {'name': 'Dasatinib', 'type': 'DRUG', 'otherNames': ['sprycel', 'sophoretin'], 'description': 'dasatinib 100mg The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined, intermittenly throughout the trial', 'armGroupLabels': ['Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine']}, {'name': 'Quercetin (dietary supplement)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['quercetine', 'Vitamin P'], 'description': 'e intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined, intermittenly throughout the trial', 'armGroupLabels': ['Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine']}, {'name': 'Vortioxetine', 'type': 'DRUG', 'otherNames': ['Trintellix', 'Brintellix'], 'description': 'Participants will be prescribed vortioxetine to take daily, in combination with online cognitive training', 'armGroupLabels': ['Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aris Perez', 'role': 'CONTACT', 'email': 'arisperez@wustl.edu', 'phone': '314-747-8906'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Aris Perez', 'role': 'CONTACT', 'email': 'arisperez@wustl.edu', 'phone': '314-747-8906'}, {'name': 'Angela Stevens', 'role': 'CONTACT', 'email': 'stevens.a@wustl.edu'}], 'overallOfficials': [{'name': 'Eric Lenze, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Contact PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}