[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560992":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":10,"centralContacts":34,"locations":40,"responsibleParty":449,"collaborators":10,"id":451,"slug":10,"hasResults":452,"nctId":453,"briefTitle":454,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":457,"sex":458,"minAge":459,"maxAge":460,"enrollmentInfo":461,"targetDuration":10,"studyType":464,"phases":10,"briefSummary":465,"conditions":466,"keywords":472,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":484},{"fullName":5,"class":6},"GAP Innovations, PBC","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitively Normal",null,"No reported memory loss or concerns as reported by participant and study partner.",[13,14],"Other: Biomarker Data Collection","Radiation: MK6240",{"label":16,"type":10,"description":17,"interventionNames":18},"Mild Cognitive Impairment","A diagnosis of Mild Cognitive Impairment (MCI) based on the National Institute of Aging (NIA) criteria and verified through medical records.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Mild-to-Moderate AD Dementia","A diagnosis of Mild-to-Moderate AD Dementia based on the National Institute of Aging (NIA) criteria and verified through medical records.",[13,14],[24,29],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"OTHER","Biomarker Data Collection","During this study, a sample of your blood will be collected and you will have a PET scan taken of your brain. Blood sample results will be compared to PET scan pictures to understand how well the markers in the blood predict whether there is amyloid in the brain. Blood samples will also be collected that contain your genes. These genetic samples will also be compared to PET scans to help researchers understand how different people react to medicines and to understand the genetic causes of AD. Some of the samples will be stored for future analysis.",[9,16,20],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"RADIATION","MK6240","Each participant will be assessed using either one of two radioactive tau PET tracers: Flortaucipir or MK6240. Flortaucipir is FDA approved while MK6240 is not and is being used in this study as an investigational radioactive drug.",[9,16,20],[35],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Amanda Ng, MA","CONTACT","biohermes-002@globalalzplatfor","biohermes-002@globalalzplatform.org",[41,62,78,94,110,126,142,158,173,189,205,221,237,253,269,286,303,314,324,335,351,368,384,403,421,436],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"JEM Research Institute","RECRUITING","Atlantis","Florida","33462","United States",{"type":49,"coordinates":50},"Point",[51,52],-80.10088,26.5909,{"lat":52,"lon":51},[55,59],{"name":56,"role":37,"phone":57,"phoneExt":10,"email":58},"Erin McBride","561-968-2933","emcbride@jemri.net",{"name":60,"role":61,"phone":10,"phoneExt":10,"email":10},"Linda Pao, MD","PRINCIPAL_INVESTIGATOR",{"facility":63,"status":43,"city":64,"state":45,"zip":65,"country":47,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Visionary Investigators Network","Aventura","33180",{"type":49,"coordinates":67},[68,69],-80.13921,25.95648,{"lat":69,"lon":68},[72,76],{"name":73,"role":37,"phone":74,"phoneExt":10,"email":75},"Nicole Rios","954-250-2379","nrios@vintrials.com",{"name":77,"role":61,"phone":10,"phoneExt":10,"email":10},"Julie Schwartzbard, MD",{"facility":79,"status":43,"city":80,"state":45,"zip":81,"country":47,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"K2 - Winter Garden","Clermont","34711",{"type":49,"coordinates":83},[84,85],-81.77285,28.54944,{"lat":85,"lon":84},[88,92],{"name":89,"role":37,"phone":90,"phoneExt":10,"email":91},"Anjali Mahavir","321-340-4786","anjali.mahavir@k2med.com",{"name":93,"role":61,"phone":10,"phoneExt":10,"email":10},"Nicholas Weber, DO",{"facility":95,"status":43,"city":96,"state":45,"zip":97,"country":47,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Brain Matters Research","Delray Beach","33445",{"type":49,"coordinates":99},[100,101],-80.07282,26.46146,{"lat":101,"lon":100},[104,108],{"name":105,"role":37,"phone":106,"phoneExt":10,"email":107},"Laura Ystha Alonso","561-374-8461 EXT 1002","RecruitmentBMR@ergclinical.com",{"name":109,"role":61,"phone":10,"phoneExt":10,"email":10},"Paayal Patel, MD",{"facility":111,"status":43,"city":112,"state":45,"zip":113,"country":47,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Neuropsychiatric Research Center of SW Florida","Fort Myers","33912",{"type":49,"coordinates":115},[116,117],-81.84059,26.62168,{"lat":117,"lon":116},[120,124],{"name":121,"role":37,"phone":122,"phoneExt":10,"email":123},"Stephanie Gillis","239-939-7777","sgillis@ergclinical.com",{"name":125,"role":61,"phone":10,"phoneExt":10,"email":10},"John Huffaker, DNP, FNP-C",{"facility":127,"status":43,"city":128,"state":45,"zip":129,"country":47,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"K2 Medical Research","Maitland","32751",{"type":49,"coordinates":131},[132,133],-81.36312,28.62778,{"lat":133,"lon":132},[136,140],{"name":137,"role":37,"phone":138,"phoneExt":10,"email":139},"Tiffany Kiako","407-447-4342","Tiffany.Kiako@k2med.com",{"name":141,"role":61,"phone":10,"phoneExt":10,"email":10},"Sheila Baez-Torres",{"facility":143,"status":43,"city":144,"state":45,"zip":145,"country":47,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Clincloud","Melbourne","32940",{"type":49,"coordinates":147},[148,149],-80.60811,28.08363,{"lat":149,"lon":148},[152,156],{"name":153,"role":37,"phone":154,"phoneExt":10,"email":155},"Erin Frank","407-680-0534","efrank@myclincloud.com",{"name":157,"role":61,"phone":10,"phoneExt":10,"email":10},"Rosemary Laird, MD",{"facility":63,"status":43,"city":159,"state":45,"zip":160,"country":47,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Miami","33133",{"type":49,"coordinates":162},[163,164],-80.19366,25.77427,{"lat":164,"lon":163},[167,171],{"name":168,"role":37,"phone":169,"phoneExt":10,"email":170},"Dayana Torres","786-655-8010","dtorres@vintrials.com",{"name":172,"role":61,"phone":10,"phoneExt":10,"email":10},"Andrew Lerman",{"facility":174,"status":43,"city":175,"state":45,"zip":176,"country":47,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Charter Research","Orlando","32803",{"type":49,"coordinates":178},[179,180],-81.37924,28.53834,{"lat":180,"lon":179},[183,187],{"name":184,"role":37,"phone":185,"phoneExt":10,"email":186},"Celynez Gomez","407-337-1000","celynez.gomez@charterresearch.com",{"name":188,"role":37,"phone":10,"phoneExt":10,"email":10},"Edgardo Rivera, MD",{"facility":190,"status":43,"city":191,"state":45,"zip":192,"country":47,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Progressive Medical Research","Port Orange","32127",{"type":49,"coordinates":194},[195,196],-80.99561,29.13832,{"lat":196,"lon":195},[199,203],{"name":200,"role":37,"phone":201,"phoneExt":10,"email":202},"Kyrie Allen","386-304-7070","kryiem@progressivemedicalresearch.com",{"name":204,"role":61,"phone":10,"phoneExt":10,"email":10},"Alexander White, MD",{"facility":206,"status":43,"city":207,"state":45,"zip":208,"country":47,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Intercoastal Medical Group, Inc.","Sarasota","34239",{"type":49,"coordinates":210},[211,212],-82.53065,27.33643,{"lat":212,"lon":211},[215,219],{"name":216,"role":37,"phone":217,"phoneExt":10,"email":218},"Jeanette Wilson","941-203-3750","jewilson@intercoastalmedical.com",{"name":220,"role":61,"phone":10,"phoneExt":10,"email":10},"Maurico Concha, MD",{"facility":222,"status":43,"city":223,"state":45,"zip":224,"country":47,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"Axiom Brain Health","Tampa","33609",{"type":49,"coordinates":226},[227,228],-82.45843,27.94752,{"lat":228,"lon":227},[231,235],{"name":232,"role":37,"phone":233,"phoneExt":10,"email":234},"Johannes Dessoy","813-353-9613","jdessoy@axiombrainhealth.com",{"name":236,"role":61,"phone":10,"phoneExt":10,"email":10},"Susan Steen, MD",{"facility":238,"status":43,"city":239,"state":45,"zip":240,"country":47,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"Conquest Research","Winter Park","32789",{"type":49,"coordinates":242},[243,244],-81.33924,28.6,{"lat":244,"lon":243},[247,251],{"name":248,"role":37,"phone":249,"phoneExt":10,"email":250},"Jairo Argueta","407-916-0060","Jairo.Argueta@conquestresearch.com",{"name":252,"role":61,"phone":10,"phoneExt":10,"email":10},"Malisa Agard",{"facility":254,"status":43,"city":255,"state":256,"zip":257,"country":47,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"Flourish Research - Chicago","Chicago","Illinois","60640",{"type":49,"coordinates":259},[260,261],-87.65005,41.85003,{"lat":261,"lon":260},[264,267],{"name":265,"role":37,"phone":266,"phoneExt":10,"email":265},"areeves@flourishresearch.com","773-275-3500",{"name":268,"role":61,"phone":10,"phoneExt":10,"email":10},"Jeffrey Ross, MD",{"facility":270,"status":43,"city":271,"state":272,"zip":273,"country":47,"cosmosGeoPoint":274,"geoPoint":278,"contacts":279},"Quest Research Institute","Farmington Hills","Michigan","48334",{"type":49,"coordinates":275},[276,277],-83.37716,42.48531,{"lat":277,"lon":276},[280,284],{"name":281,"role":37,"phone":282,"phoneExt":10,"email":283},"Jorge Isunza","248-957-8940","jorge.isunza@questri.com",{"name":285,"role":61,"phone":10,"phoneExt":10,"email":10},"Aaron Ellenbogen, MD",{"facility":287,"status":43,"city":288,"state":289,"zip":290,"country":47,"cosmosGeoPoint":291,"geoPoint":295,"contacts":296},"Clinical Neurology Specialists","Las Vegas","Nevada","89147",{"type":49,"coordinates":292},[293,294],-115.13722,36.17497,{"lat":294,"lon":293},[297,301],{"name":298,"role":37,"phone":299,"phoneExt":10,"email":300},"Sarah Freeland","702-381-2882","LasVegasResearch@GlobalAlzPlatform.org",{"name":302,"role":61,"phone":10,"phoneExt":10,"email":10},"Leo Germin, MD",{"facility":304,"status":305,"city":306,"state":307,"zip":308,"country":47,"cosmosGeoPoint":309,"geoPoint":313,"contacts":10},"ADRC of Albany","COMPLETED","Albany","New York","12208",{"type":49,"coordinates":310},[311,312],-73.75623,42.65258,{"lat":312,"lon":311},{"facility":315,"status":305,"city":316,"state":317,"zip":318,"country":47,"cosmosGeoPoint":319,"geoPoint":323,"contacts":10},"Neuro-Behavioral Clinical Research Inc.","North Canton","Ohio","44720",{"type":49,"coordinates":320},[321,322],-81.40234,40.87589,{"lat":322,"lon":321},{"facility":325,"status":326,"city":327,"state":328,"zip":329,"country":47,"cosmosGeoPoint":330,"geoPoint":334,"contacts":10},"Flourish Research - Philadelphia","ACTIVE_NOT_RECRUITING","Philadelphia","Pennsylvania","19462",{"type":49,"coordinates":331},[332,333],-75.16362,39.95238,{"lat":333,"lon":332},{"facility":127,"status":43,"city":336,"state":337,"zip":338,"country":47,"cosmosGeoPoint":339,"geoPoint":343,"contacts":344},"East Providence","Rhode Island","02914",{"type":49,"coordinates":340},[341,342],-71.37005,41.81371,{"lat":342,"lon":341},[345,349],{"name":346,"role":37,"phone":347,"phoneExt":10,"email":348},"Sam Slezak","401-209-1079","sam.slezak@k2med.com",{"name":350,"role":61,"phone":10,"phoneExt":10,"email":10},"Daniel Sacchetti, MD",{"facility":352,"status":43,"city":353,"state":354,"zip":355,"country":47,"cosmosGeoPoint":356,"geoPoint":360,"contacts":361},"Gadolin Research LLC","Beaumont","Texas","77702",{"type":49,"coordinates":357},[358,359],-94.10185,30.08605,{"lat":359,"lon":358},[362,366],{"name":363,"role":37,"phone":364,"phoneExt":10,"email":365},"Alexia Tran","(409) 331-6040","atran@gadolin.com",{"name":367,"role":61,"phone":10,"phoneExt":10,"email":10},"Kandasami Senthilkumar, MD",{"facility":369,"status":43,"city":370,"state":354,"zip":371,"country":47,"cosmosGeoPoint":372,"geoPoint":376,"contacts":377},"Re:Cognition Health","Houston","77030",{"type":49,"coordinates":373},[374,375],-95.36327,29.76328,{"lat":375,"lon":374},[378,382],{"name":379,"role":37,"phone":380,"phoneExt":10,"email":381},"Laura Vaquerano","(346)568-0809","lvaquerano@re-cognitionhealth.com",{"name":383,"role":61,"phone":10,"phoneExt":10,"email":10},"Avni Kapadia, MD",{"facility":385,"status":43,"city":386,"state":387,"zip":388,"country":389,"cosmosGeoPoint":390,"geoPoint":394,"contacts":395},"Toronto Memory Program","Toronto","Ontario","M3B 2S7","Canada",{"type":49,"coordinates":391},[392,393],-79.39864,43.70643,{"lat":393,"lon":392},[396,401],{"name":397,"role":37,"phone":398,"phoneExt":399,"email":400},"Barathy Tharmalingam","416-386-9761","ext. 310","barathy.tharmalingam@memorydisorders.ca",{"name":402,"role":61,"phone":10,"phoneExt":10,"email":10},"Sharon Cohen, MD",{"facility":404,"status":43,"city":405,"state":406,"zip":407,"country":408,"cosmosGeoPoint":409,"geoPoint":413,"contacts":414},"NeuroClin Glasgow","Motherwell","North Lanarkshire","ML1 4UF","United Kingdom",{"type":49,"coordinates":410},[411,412],-3.99187,55.78924,{"lat":412,"lon":411},[415,419],{"name":416,"role":37,"phone":417,"phoneExt":10,"email":418},"Erin McCrone","0141 948 0206","erin.mccrone@neuroclin.co.uk",{"name":420,"role":61,"phone":10,"phoneExt":10,"email":10},"Jennifer Lynch, MD",{"facility":369,"status":43,"city":422,"state":10,"zip":423,"country":408,"cosmosGeoPoint":424,"geoPoint":428,"contacts":429},"London","W1G 8TA",{"type":49,"coordinates":425},[426,427],-0.12574,51.50853,{"lat":427,"lon":426},[430,434],{"name":431,"role":37,"phone":432,"phoneExt":10,"email":433},"Amelia Buttifant","(0)20 3355 3536","abuttifant@re-cognitionhealth.com",{"name":435,"role":61,"phone":10,"phoneExt":10,"email":10},"Emer Macsweeney, MD",{"facility":437,"status":43,"city":422,"state":10,"zip":438,"country":408,"cosmosGeoPoint":439,"geoPoint":441,"contacts":442},"Dementia Research Centre, UCLH","WC1N 3BG",{"type":49,"coordinates":440},[426,427],{"lat":427,"lon":426},[443,447],{"name":444,"role":37,"phone":445,"phoneExt":10,"email":446},"Mobeen Fazal","0203 448 3054","mobeen.fazal1@nhs.net",{"name":448,"role":61,"phone":10,"phoneExt":10,"email":10},"Catherine Mummery, MD",{"type":450,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100560992",false,"NCT06584357","Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia","Bio-Hermes-002","Inclusion Criteria:\n\nPre-screening Inclusion Criteria\n\nParticipants must meet ALL of the following criteria to progress to Visit 1 (Screening):\n\n1. Participant is between 60 to 90 years of age (inclusive) at the time of consent; and\n2. Participant has a study partner who has sufficient and frequent contact with the participant (defined as at least 8 hours of contact a week) and is able to provide accurate information regarding the participant's cognitive and functional abilities.\n\nCore Study Inclusion Criteria\n\nParticipants must meet ALL of the following criteria, in addition to the Pre-screening Inclusion Criteria, for entry into the study:\n\n1. Participants must provide written consent in the IRB-approved or Ethics Committee (EC) approved informed consent form or have a legally authorized representative (LAR) provide written consent on the participant's behalf in accordance with local and national guidance and regulation;\n2. Participants must be willing to undergo an MRI brain scan within 90 days and an amyloid and tau PET scan within 120 days of signing informed consent;\n3. Participants must be willing to comply with all study procedures as outlined in the informed consent, including blood sampling, genetic testing, and storage of biospecimens for future research;\n4. Fluency in the language of the tests used at the study site;\n5. Participants must be willing to be contacted for possible participation in clinical research trials once their participation in this study ends; and\n6. Participants must have a Mini-Mental State Exam (MMSE) score of 16 to 30 inclusive at screening.\n\nExclusion Criteria:\n\nPre-screening Exclusion Criteria\n\nParticipants who meet ANY of the following criteria will not be eligible to progress to Visit 1 (Screening):\n\n1. Participant is unable to undergo amyloid and tau PET scans due to self-reported pregnancy, sensitivity to ligands being used, poor venous access, contraindication to PET, or planned or recent exposure to ionizing radiation that in combination with the planned administration of amyloid radioligand would result in a cumulative exposure that exceeds recommended local guidelines;\n2. Participants who have reported or have a known negative amyloid PET scan in the past 6 months;\n3. Participants with any known contraindication to brain MRI scan;\n4. Participants with history of stroke or seizures within 1 year of the Pre-Screening Visit;\n5. Participants with history of cancer within the past 5 years with the exception of non-melanoma skin cancer or prostate cancer in situ;\n6. Participants with known or suspected alcohol or drug abuse or dependence within 1 year of the Pre- Screening Visit;\n7. Participants who report any current unstable psychiatric symptoms that could interfere with study procedures or impact study data (e.g., uncontrolled depression);\n8. Participants who have received any potential disease modifying AD treatment within 6 months prior to the Pre-screening Visit; and\n9. Participants with known history or self-report to be Human Immunodeficiency Virus (HIV) Positive unless controlled by antiviral medication.\n\nCore Study Exclusion Criteria\n\nParticipants who meet ANY of the following criteria, in addition to the Pre-screening Exclusion Criteria, will not be eligible to enroll into the study:\n\n1. Participants who, in the opinion of the Site Principal Investigator, have serious or unstable medical conditions that would prohibit their completion of all study procedures and data collection;\n2. Participants who have serious or unstable medical conditions that would likely preclude their participation in an interventional research trial;\n3. Participants with self-reported, untreated conditions such as vitamin B12 or folate deficiency or bladder infections that in the opinion of the Site Principal Investigator could contribute to cognitive impairment;\n4. Participants who have completed cognitive testing within 1 month of Visit 1 (Screening) where the Site Principal Investigator believes the participant's exposure may cause practice effect;\n5. Participants who have any neurological disorder affecting the central nervous system, other than AD, that may be contributing to cognitive impairment (e.g., Parkinson's disease, other dementias, multiple concussions or seizures) as deemed significant by the Site Principal Investigator;\n6. Participants with a Geriatric Depression Scale (GDS) score greater than or equal to 8 at Visit 1 (Screening) and is deemed to be clinically significantly depressed by the Site Principal Investigator;\n7. Participants with a Rey Auditory Verbal Learning Test (RAVLT) t-score of ≥ 1.2 standard deviation above the mean. For non-African Americans, calculate age-sex-education adjusted t-scores. For African American participants, use the MOANS to calculate the age-education adjusted t-scores;\n8. Participants weighing less than 110 pounds;\n9. Participants who are direct employees or family members of direct employees of the participating investigators' sites;\n10. Participants who are direct employees of the Sponsor;\n11. Participants who, in the opinion of the investigator, are unable to complete cognitive testing due to inadequate visual or auditory acuity; and\n12. For participants completing the RetiSpec retinal scan: Those with a known history of contraindication or allergy to Tropicamide 1% (pupil dilation drop).\n\nLongitudinal Sub-Study Eligibility\n\nInclusion Criteria:\n\nParticipants must meet ALL of the following criteria for entry into the sub-study:\n\n1. Participants who completed the Bio-Hermes-002 Core Study;\n2. Are willing to complete phone call visits with site staff every three months and return to the clinic for an annual evaluation; and\n3. Are willing to complete annual PET scans for both amyloid and tau scans.\n\nExclusion Criteria:\n\nParticipants who meet ANY of the following criteria will not be eligible for entry into the sub-study:\n\n1. Those who are enrolled or intend to enroll into a clinical trial for Alzheimer's disease with a potential disease-modifying intervention;\n2. Participants who have serious or unstable medical conditions that would likely preclude their participation in an interventional research trial;\n3. Those who intend to use medications outside clinical research studies approved by regulatory authorities to modify Alzheimer's disease pathology.",true,"ALL","60 Years","90 Years",{"count":462,"type":463},1200,"ESTIMATED","OBSERVATIONAL","Bio-Hermes-002 is a 120-day cross-sectional study that will result in a blood, CSF, retinal, digital, MRI, and PET brain imaging biomarker database that can be used to determine the primary objective. Digital biomarkers and blood-based biomarkers will be tested to determine whether a meaningful relationship exists between biomarkers alone or in combination with tau or amyloid brain pathology identified through PET images.",[16,467,468,469,470,471],"Alzheimer's Disease","Alzheimer's Disease, Early Onset","Memory Loss","Memory Disorders","Memory Impairment",[467,468,16,473,474,469,470,471],"Older Volunteers","Healthy Volunteers","2026-04-13",{"date":477,"type":478},"2026-04-15","ACTUAL",{"date":480,"type":478},"2024-09-26",{"date":482,"type":463},"2028-07",{"name":5,"class":6},26]