protocolSection identificationModule nctId: NCT06304883, orgStudyIdInfo id: ALZ-801-AD351, briefTitle: Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects, acronym: APOLLOE4-LTE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Alzheon Inc., class: INDUSTRY, descriptionModule briefSummary: This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801., conditionsModule conditions: Early Alzheimer's Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a multi-center, open-label, single group, long-term extension study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 285, type: ESTIMATED, armsInterventionsModule interventions name: Experimental: ALZ-801, outcomesModule primaryOutcomes measure: Primary cognitive efficacy endpoint 1, primaryOutcomes measure: Primary cognitive efficacy endpoint 2, primaryOutcomes measure: Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAEs), primaryOutcomes measure: Primary imaging biomarker endpoint 1, primaryOutcomes measure: Primary imaging biomarker endpoint 2, secondaryOutcomes measure: Secondary functional efficacy endpoint, secondaryOutcomes measure: Secondary global assessment efficacy endpoint, secondaryOutcomes measure: Secondary cognitive efficacy endpoint 1, secondaryOutcomes measure: Secondary cognitive efficacy endpoint 2, secondaryOutcomes measure: Secondary cognitive efficacy endpoint 3, secondaryOutcomes measure: Secondary imaging biomarker endpoint, secondaryOutcomes measure: Secondary fluid biomarker endpoint, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xenoscience, Inc., city: Phoenix, state: Arizona, zip: 85004, country: United States, contacts name: Stephen Flitman, role: CONTACT, phone: 602-274-9500, email: sflitman@xenoscience.com, contacts name: Stephen Flitman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Banner Sun Health Research Institute, city: Sun City, state: Arizona, zip: 85351, country: United States, contacts name: Michele R Gutierrez, role: CONTACT, phone: 623-832-5706, email: Michele.Gutierrez@bannerhealth.com, contacts name: Alireza Atri, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.59754, lon: -112.27182, locations facility: ATP Clinical Research, city: Costa Mesa, state: California, zip: 92626, country: United States, contacts name: Bobby Shih, role: CONTACT, phone: 714-277-4472, email: bshih@atpcr.com, contacts name: Gustavo Alva, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.64113, lon: -117.91867, locations facility: Torrance Clinical Research Institute, city: Lomita, state: California, zip: 90717, country: United States, contacts name: Valeria Herrera, role: CONTACT, phone: 310-373-8120, email: mraikhel@msn.com, contacts name: Marina Raikhel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.79224, lon: -118.31507, locations facility: Sutter Health, city: Sacramento, state: California, zip: 95816, country: United States, contacts name: Dawn R Lenakakis, role: CONTACT, phone: 916-887-4734, email: Dawn.Lenakakis@sutterhealth.org, contacts name: Shawn Kile, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.58157, lon: -121.4944, locations facility: Tilda Research, Inc., city: Tustin, state: California, zip: 92780, country: United States, contacts name: Shahrnaz Jamshidi, role: CONTACT, phone: 949-569-6444, email: shahrnaz.jamshidi@tilda.bio, contacts name: Erik Geiger, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.74585, lon: -117.82617, locations facility: JEM Research Institute, Headlands Site, city: Atlantis, state: Florida, zip: 33462, country: United States, contacts name: Mark Goldstein, role: CONTACT, phone: 561-968-2933, email: Mgoldstein@jemri.net, contacts name: Mark Goldstein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.5909, lon: -80.10088, locations facility: Bradenton Research Center, city: Bradenton, state: Florida, zip: 34205, country: United States, contacts name: Michelle Scott, role: CONTACT, phone: 941-708-0005, email: michellescott@bradentonresearch.com, contacts name: Eric Folkens, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.49893, lon: -82.57482, locations facility: Alphab Global Research, city: Jupiter, state: Florida, zip: 33458, country: United States, contacts name: Teresa Villena, role: CONTACT, phone: 561-301-8286, email: t.villena@aol.com, contacts name: Gerald O'Connor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.93422, lon: -80.09421, locations facility: K2 Medical Research, LLC, city: Maitland, state: Florida, zip: 32751, country: United States, contacts name: Gina Cedano, role: CONTACT, phone: 321-221-7806, email: Gina.Cedano@k2med.com, contacts name: Brandon Lenox, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.62778, lon: -81.36312, locations facility: Mount Sinai Medical Center, city: Miami Beach, state: Florida, zip: 33140, country: United States, contacts name: Mileidys Herrera, role: CONTACT, phone: 350-674-2121, phoneExt: 54881, email: Mileidys.herrera@msmc.com, contacts name: Ranjan Duara, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.79065, lon: -80.13005, locations facility: Aqualane Clinical Research, city: Naples, state: Florida, zip: 34105, country: United States, contacts name: Kelly Calistri, role: CONTACT, phone: 239-434-0332, email: Kelly@aqualaneresearch.com, contacts name: William Justiz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.14234, lon: -81.79596, locations facility: Headlands Research Orlando, city: Orlando, state: Florida, zip: 32819, country: United States, contacts name: Jennifer Thompson, role: CONTACT, phone: 407-705-3471, email: jennifer.thompson@headlandsresearch.com, contacts name: Theodore Lee, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Progressive Medical Research, city: Port Orange, state: Florida, zip: 32127, country: United States, contacts name: Chantelle Funge, role: CONTACT, phone: 386-304-7070, phoneExt: 3205, email: chantellef@progressivemedicalresearch.com, contacts name: Alexander White, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.13832, lon: -80.99561, locations facility: ALZ Research and Treatment Center (A.R.T.C.), city: Stuart, state: Florida, zip: 34997, country: United States, contacts name: David Watson, role: CONTACT, phone: 772-675-0000, email: dwatson@researchalz.com, contacts name: David Watson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.19755, lon: -80.25283, locations facility: ALZ Research and Treatment Center (A.R.T.C.), city: Wellington, state: Florida, zip: 33414, country: United States, contacts name: David Watson, role: CONTACT, phone: 561-209-2400, email: dwatson@researchalz.com, contacts name: David Watson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.65868, lon: -80.24144, locations facility: Premiere Research Institute, city: West Palm Beach, state: Florida, zip: 33407, country: United States, contacts name: Paul Winner, role: CONTACT, phone: 561-845-0500, phoneExt: 102, email: Pwinner777@aol.com, contacts name: Paul Winner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.71534, lon: -80.05337, locations facility: Charter Research, city: Winter Park, state: Florida, zip: 32792, country: United States, contacts name: Celynez Gomez, role: CONTACT, phone: 407-337-1000, phoneExt: 3001, email: celynez.gomez@charterresearch.com, contacts name: Edgardo J Rivera, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.6, lon: -81.33924, locations facility: Columbus Memory Center, city: Columbus, state: Georgia, zip: 31909, country: United States, contacts name: Jonathan Liss, role: CONTACT, phone: 706-653-8455, email: jliss@researchcmc.com, contacts name: Jonathan Liss, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.46098, lon: -84.98771, locations facility: Fort Wayne Neurological Center, city: Fort Wayne, state: Indiana, zip: 46804, country: United States, contacts name: Patti Case, role: CONTACT, phone: 260-436-3991, phoneExt: 2202, email: pcase@fwnc.com, contacts name: James Stevens, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.1306, lon: -85.12886, locations facility: Headlands Research Eastern MA, city: Plymouth, state: Massachusetts, zip: 02360, country: United States, contacts name: Brandon Hatch, role: CONTACT, phone: 508-746-5060, email: brandon.hatch@headlandsresearcheema.com, contacts name: Donald Marks, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.95844, lon: -70.66726, locations facility: Advanced Memory Research Center, city: Toms River, state: New Jersey, zip: 08755, country: United States, contacts name: Anna Brocco, role: CONTACT, phone: 732-341-9500, email: ABrocco@amrinj.com, contacts name: Sanjiv Sharma, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95373, lon: -74.19792, locations facility: Neurological Associates of Albany, city: Albany, state: New York, zip: 12208, country: United States, contacts name: Richard Holub, role: CONTACT, phone: 518-426-0575, email: research@naaresearch.com, contacts name: Richard Holub, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.65258, lon: -73.75623, locations facility: NYU Alzheimer's Disease Research Center, city: New York, state: New York, zip: 10016, country: United States, contacts name: Brittany Marti, role: CONTACT, phone: 212-263-5708, email: Brittany.Marti@nyulangone.org, contacts name: Thomas Wisniewski, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Kline Institute for Psychiatric Research, city: Orangeburg, state: New York, zip: 10962, country: United States, contacts name: Nunzio Pomara, role: CONTACT, phone: 845-398-5579, email: Nunzio.Pomara@nki.rfmh.org, contacts name: Nunzio Pomara, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.04649, lon: -73.94958, locations facility: University of Rochester Medical Center, city: Rochester, state: New York, zip: 14620, country: United States, contacts name: Nancy A Kowalski, role: CONTACT, phone: 585-602-5205, email: Nancy_Kowalski@urmc.rochester.edu, contacts name: Emily Clark, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.15478, lon: -77.61556, locations facility: Triad Clinical Trials, city: Greensboro, state: North Carolina, zip: 27410, country: United States, contacts name: Scott Whitt, role: CONTACT, phone: 336-235-0991, email: swhitt@triadclinicaltrials.com, contacts name: Richard Montgomery, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.07264, lon: -79.79198, locations facility: AMC Research, city: Matthews, state: North Carolina, zip: 28105, country: United States, contacts name: Shereen Bolouri, role: CONTACT, phone: 704-364-4000, phoneExt: 235, email: ssbolouri@amcneurology.com, contacts name: Mohammad R Bolouri, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.11681, lon: -80.72368, locations facility: Center for Cognitive Health, city: Portland, state: Oregon, zip: 97225, country: United States, contacts name: Ericka Eyton, role: CONTACT, phone: 503-548-0908, email: ericka@centerforcognitivehealth.com, contacts name: Michael Mega, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Abington Neurological Associates, city: Abington, state: Pennsylvania, zip: 19001, country: United States, contacts name: Kareema Murray, role: CONTACT, phone: 215-957-9250, email: kareemamurray.ana@gmail.com, contacts name: David Weisman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.12067, lon: -75.11795, locations facility: Rhode Island Mood & Memory Research Institute, city: East Providence, state: Rhode Island, zip: 02914, country: United States, contacts name: Lynn Rainville, role: CONTACT, phone: 401-435-8950, email: lrainville@rimmri.com, contacts name: John Stoukides, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.81371, lon: -71.37005, locations facility: UT Health Science Center at Houston, city: Houston, state: Texas, zip: 77054, country: United States, contacts name: Alexa Bavero, role: CONTACT, phone: 713-486-0501, email: Alexa.Bavero@uth.tmc.edu, contacts name: Paul Schulz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Re:Cognition Health, city: Fairfax, state: Virginia, zip: 22031, country: United States, contacts name: Maria Toor, role: CONTACT, phone: 703-520-9703, email: mtoor@re-cognitionhealth.com, contacts name: Raymond S Turner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.84622, lon: -77.30637, locations facility: Northwest Clinical Research Center, city: Bellevue, state: Washington, zip: 98007, country: United States, contacts name: Arifulla Khan, role: CONTACT, phone: 425-453-0404, email: study.coordinator@nwcrc.net, contacts name: Arifulla Khan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.61038, lon: -122.20068, locations facility: OCT Research ULC (dba Okanagan Clinical Trials), city: Kelowna, state: British Columbia, zip: V1Y 1Z9, country: Canada, contacts name: Robert Goldberg, role: CONTACT, phone: 250-862-8141, email: Robert@oktrials.ca, contacts name: Eugene Okorie, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.88307, lon: -119.48568, locations facility: Centricity Research, city: Halifax, state: Nova Scotia, zip: B3S 1N2, country: Canada, contacts name: Gagan Oberoi, role: CONTACT, phone: 902-431-8783, phoneExt: 7107, email: Gagan.oberoi@centricityresearch.com, contacts name: Fred Archibald, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.64533, lon: -63.57239, locations facility: Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic, city: Ottawa, state: Ontario, zip: K1Z 1G3, country: Canada, contacts name: Richard Bergeron, role: CONTACT, phone: 613-702-1000, email: rbergeron@cliniquememoire.ca, contacts name: Richard Bergeron, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.41117, lon: -75.69812, locations facility: Kawartha Centre - Redefining Healthy Aging, city: Peterborough, state: Ontario, zip: K9H 2P4, country: Canada, contacts name: Jill MacPhee, role: CONTACT, phone: 705-749-3906, phoneExt: 213, email: jill@kawarthacentre.com, contacts name: Katie Krause, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.30012, lon: -78.31623, locations facility: Toronto Memory Program, city: Toronto, state: Ontario, zip: M3B 2S7, country: Canada, contacts name: Justine Reaume, role: CONTACT, phone: 416-386-9761, phoneExt: 364, email: jreaume@memorydisorders.ca, contacts name: Sharon Cohen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Re-Cognition Health Ltd Plymouth, city: Plymouth, state: Devon, zip: PL6 8BT, country: United Kingdom, contacts name: Victoria Evans, role: CONTACT, phone: +44 1752875604, email: vevans@re-cognitionhealth.com, contacts name: Stephen Pearson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.37153, lon: -4.14305, locations facility: Re-Cognition Health Ltd London, city: London, state: Greater London, zip: W1G 9JF, country: United Kingdom, contacts name: Josephine E MacSweeney, role: CONTACT, phone: +44 2033553536, email: emacsweeney@re-cognitionhealth.com, contacts name: Josephine E MacSweeney, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: NeuroClin Glasgow Ltd, city: Motherwell, state: North Lanarkshire, zip: ML1 4UF, country: United Kingdom, contacts name: Jennifer Lynch, role: CONTACT, phone: +44 1419480206, email: jennifer.lynch@neuroclin.co.uk, contacts name: Jennifer Lynch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.78924, lon: -3.99187, locations facility: Re-Cognition Health Ltd Guildford, city: Guildford, state: Surrey, zip: GU2 7YD, country: United Kingdom, contacts name: Nicholas Mannering, role: CONTACT, phone: +44 1483941982, email: NMannering@re-cognitionhealth.com, contacts name: Nicholas Mannering, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.23536, lon: -0.57427, locations facility: Re-Cognition Health Ltd Birmingham, city: Birmingham, state: West Midlands, zip: B16 8LT, country: United Kingdom, contacts name: Conor Clerkin-Oliver, role: CONTACT, phone: +44 1216550166, email: cclerkin@re-cognitionhealth.com, contacts name: Conor Clerkin-Oliver, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.48142, lon: -1.89983, locations facility: Re-Cognition Health Ltd Bristol, city: Bristol, zip: BS32 4SY, country: United Kingdom, contacts name: Daniel Lashley, role: CONTACT, phone: +44 1174623600, email: dlashley@re-cognitionhealth.com, contacts name: Daniel Lashley, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.45523, lon: -2.59665, locations facility: Re-Cognition Health Ltd Winchester, city: Winchester, zip: SO21 1HU, country: United Kingdom, contacts name: Anna Podonyi, role: CONTACT, phone: +44 1962588420, email: apodonyi@re-cognitionhealth.com, contacts name: Steven J Allder, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.06513, lon: -1.3187, hasResults: False