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