{"id":"https://openalex.org/W7224106958","doi":"https://doi.org/10.17219/fpn/242038","title":"Vaccines against Alzheimer\u2019s disease: Clinical trial evidence, safety and endpoint design","display_name":"Vaccines against Alzheimer\u2019s disease: Clinical trial evidence, safety and endpoint design","publication_year":2026,"publication_date":"2026-10-28","ids":{"openalex":"https://openalex.org/W7224106958","doi":"https://doi.org/10.17219/fpn/242038"},"language":"en","primary_location":{"id":"doi:10.17219/fpn/242038","doi":"https://doi.org/10.17219/fpn/242038","is_oa":true,"landing_page_url":"https://doi.org/10.17219/fpn/242038","pdf_url":"https://ojs.umw.edu.pl/files/ppn/FPN-277-UncorrectedProof.pdf","source":{"id":"https://openalex.org/S4210181403","display_name":"Pharmacotherapy in Psychiatry and Neurology","issn_l":"1234-8279","issn":["1234-8279","2449-9315"],"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":["poland-20"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pharmacotherapy in Psychiatry and Neurology","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://ojs.umw.edu.pl/files/ppn/FPN-277-UncorrectedProof.pdf","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5107677102","display_name":"Wiktor Gawe\u0142czyk","orcid":"https://orcid.org/0009-0005-0394-7835","observed_orcids":["https://orcid.org/0009-0005-0394-7835"]},"institutions":[{"id":"https://openalex.org/I385303915","display_name":"Wroclaw Medical University","ror":"https://ror.org/01qpw1b93","country_code":"PL","type":"education","lineage":["https://openalex.org/I385303915"]}],"countries":["PL"],"is_corresponding":false,"raw_author_name":"Wiktor Tomasz Gawe\u0142czyk","raw_affiliation_strings":["Student Scientific Group of Heart Diseases , Wroclaw Medical University , Poland"],"raw_orcid":"https://orcid.org/0009-0005-0394-7835","affiliations":[{"raw_affiliation_string":"Student Scientific Group of Heart Diseases , Wroclaw Medical University , Poland","institution_ids":["https://openalex.org/I385303915"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5093059652","display_name":"James Chmiel","orcid":"https://orcid.org/0009-0005-5320-3658","observed_orcids":["https://orcid.org/0009-0005-5320-3658"]},"institutions":[{"id":"https://openalex.org/I104588304","display_name":"University of Szczecin","ror":"https://ror.org/05vmz5070","country_code":"PL","type":"education","lineage":["https://openalex.org/I104588304"]}],"countries":["PL"],"is_corresponding":false,"raw_author_name":"James Chmiel","raw_affiliation_strings":["Faculty of Physical Culture and Health , Institute of Physical Culture Sciences , University of Szczecin , Poland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Faculty of Physical Culture and Health , Institute of Physical Culture Sciences , University of Szczecin , Poland","institution_ids":["https://openalex.org/I104588304"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5055213999","display_name":"Jerzy Leszek","orcid":"https://orcid.org/0000-0002-2316-2470","observed_orcids":["https://orcid.org/0000-0002-2316-2470"]},"institutions":[{"id":"https://openalex.org/I385303915","display_name":"Wroclaw Medical University","ror":"https://ror.org/01qpw1b93","country_code":"PL","type":"education","lineage":["https://openalex.org/I385303915"]}],"countries":["PL"],"is_corresponding":false,"raw_author_name":"Jerzy Leszek","raw_affiliation_strings":["Department of Psychiatry , Wroclaw Medical University , Poland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Psychiatry , Wroclaw Medical University , Poland","institution_ids":["https://openalex.org/I385303915"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.83905,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"42","issue":"2","first_page":"0","last_page":"0"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10086","display_name":"Alzheimer's disease research and treatments","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/2737","display_name":"Physiology (medical)"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10086","display_name":"Alzheimer's disease research and treatments","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/2737","display_name":"Physiology (medical)"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10009","display_name":"Dementia and Cognitive Impairment Research","score":0.0003000000142492354,"subfield":{"id":"https://openalex.org/subfields/2738","display_name":"Psychiatry and Mental health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11266","display_name":"Neuroinflammation and Neurodegeneration Mechanisms","score":9.999999747378752e-05,"subfield":{"id":"https://openalex.org/subfields/2808","display_name":"Neurology"},"field":{"id":"https://openalex.org/fields/28","display_name":"Neuroscience"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/alzheimer-s-disease","display_name":"Alzheimer's disease","score":0.8799999952316284},{"id":"https://openalex.org/keywords/active-immunization","display_name":"active immunization","score":0.8009999990463257},{"id":"https://openalex.org/keywords/alzheimer-s-disease-vaccine","display_name":"Alzheimer's disease vaccine","score":0.8679999709129333},{"id":"https://openalex.org/keywords/amyloid-beta","display_name":"amyloid-beta","score":0.5490000247955322},{"id":"https://openalex.org/keywords/tau-protein","display_name":"tau protein","score":0.8429999947547913},{"id":"https://openalex.org/keywords/meningoencephalitis","display_name":"meningoencephalitis","score":0.8289999961853027},{"id":"https://openalex.org/keywords/vasogenic-edema","display_name":"vasogenic edema","score":0.878000020980835},{"id":"https://openalex.org/keywords/microhemorrhages","display_name":"microhemorrhages","score":0.8840000033378601},{"id":"https://openalex.org/keywords/vaccine-safety","display_name":"vaccine safety","score":0.527999997138977},{"id":"https://openalex.org/keywords/clinical-trial-endpoints","display_name":"clinical trial endpoints","score":0.6520000100135803},{"id":"https://openalex.org/keywords/immunogenicity","display_name":"immunogenicity","score":0.6589999794960022},{"id":"https://openalex.org/keywords/adjuvants","display_name":"adjuvants","score":0.7739999890327454},{"id":"https://openalex.org/keywords/th2-response","display_name":"Th2 immune response","score":0.8119999766349792},{"id":"https://openalex.org/keywords/b-cell-epitopes","display_name":"B-cell epitopes","score":0.6639999747276306},{"id":"https://openalex.org/keywords/t-cell-epitopes","display_name":"T cell epitopes","score":0.7900000214576721},{"id":"https://openalex.org/keywords/cognitive-outcomes","display_name":"cognitive outcomes","score":0.5879999995231628},{"id":"https://openalex.org/keywords/disease-modifying-therapy","display_name":"disease-modifying therapy","score":0.6100000143051147}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.8482999801635742},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.6549999713897705},{"id":"https://openalex.org/C2780801004","wikidata":"https://www.wikidata.org/wiki/Q1415366","display_name":"Immunization","level":3,"score":0.5922999978065491},{"id":"https://openalex.org/C203092338","wikidata":"https://www.wikidata.org/wiki/Q1340863","display_name":"Clinical endpoint","level":3,"score":0.5569999814033508},{"id":"https://openalex.org/C2778715236","wikidata":"https://www.wikidata.org/wiki/Q55622662","display_name":"Discontinuation","level":2,"score":0.4943000078201294},{"id":"https://openalex.org/C177713679","wikidata":"https://www.wikidata.org/wiki/Q679690","display_name":"Intensive care medicine","level":1,"score":0.4677000045776367},{"id":"https://openalex.org/C203014093","wikidata":"https://www.wikidata.org/wiki/Q101929","display_name":"Immunology","level":1,"score":0.46639999747276306},{"id":"https://openalex.org/C2778621254","wikidata":"https://www.wikidata.org/wiki/Q2346415","display_name":"Meningoencephalitis","level":2,"score":0.45249998569488525},{"id":"https://openalex.org/C2779134260","wikidata":"https://www.wikidata.org/wiki/Q12136","display_name":"Disease","level":2,"score":0.4490000009536743},{"id":"https://openalex.org/C195616568","wikidata":"https://www.wikidata.org/wiki/Q128711","display_name":"Epitope","level":3,"score":0.4207000136375427},{"id":"https://openalex.org/C2909914741","wikidata":"https://www.wikidata.org/wiki/Q256289","display_name":"Endpoint Determination","level":3,"score":0.3813000023365021},{"id":"https://openalex.org/C8891405","wikidata":"https://www.wikidata.org/wiki/Q1059","display_name":"Immune system","level":2,"score":0.3467000126838684},{"id":"https://openalex.org/C2780868878","wikidata":"https://www.wikidata.org/wiki/Q1660197","display_name":"Immunogenicity","level":3,"score":0.33340001106262207},{"id":"https://openalex.org/C147483822","wikidata":"https://www.wikidata.org/wiki/Q103537","display_name":"Antigen","level":2,"score":0.3312000036239624},{"id":"https://openalex.org/C148482608","wikidata":"https://www.wikidata.org/wiki/Q17007018","display_name":"Clinical study design","level":3,"score":0.31709998846054077},{"id":"https://openalex.org/C159654299","wikidata":"https://www.wikidata.org/wiki/Q79460","display_name":"Antibody","level":2,"score":0.3073999881744385},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.29249998927116394},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.2809999883174896},{"id":"https://openalex.org/C187212893","wikidata":"https://www.wikidata.org/wiki/Q123028","display_name":"Pediatrics","level":1,"score":0.2768999934196472},{"id":"https://openalex.org/C542903549","wikidata":"https://www.wikidata.org/wiki/Q422248","display_name":"Monoclonal antibody","level":3,"score":0.26649999618530273},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.262800008058548},{"id":"https://openalex.org/C2779974597","wikidata":"https://www.wikidata.org/wiki/Q28448986","display_name":"Clinical Practice","level":2,"score":0.2612999975681305},{"id":"https://openalex.org/C45189115","wikidata":"https://www.wikidata.org/wiki/Q502159","display_name":"Serology","level":3,"score":0.25540000200271606}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.17219/fpn/242038","doi":"https://doi.org/10.17219/fpn/242038","is_oa":true,"landing_page_url":"https://doi.org/10.17219/fpn/242038","pdf_url":"https://ojs.umw.edu.pl/files/ppn/FPN-277-UncorrectedProof.pdf","source":{"id":"https://openalex.org/S4210181403","display_name":"Pharmacotherapy in Psychiatry and Neurology","issn_l":"1234-8279","issn":["1234-8279","2449-9315"],"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":["poland-20"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pharmacotherapy in Psychiatry and Neurology","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.17219/fpn/242038","doi":"https://doi.org/10.17219/fpn/242038","is_oa":true,"landing_page_url":"https://doi.org/10.17219/fpn/242038","pdf_url":"https://ojs.umw.edu.pl/files/ppn/FPN-277-UncorrectedProof.pdf","source":{"id":"https://openalex.org/S4210181403","display_name":"Pharmacotherapy in Psychiatry and Neurology","issn_l":"1234-8279","issn":["1234-8279","2449-9315"],"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":["poland-20"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pharmacotherapy in Psychiatry and Neurology","raw_type":"journal-article"},"sustainable_development_goals":[{"score":1.0,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W7224106958.pdf","grobid_xml":"https://content.openalex.org/works/W7224106958.grobid-xml"},"referenced_works_count":72,"referenced_works":["https://openalex.org/W1511517753","https://openalex.org/W1528113046","https://openalex.org/W1616122655","https://openalex.org/W1967549235","https://openalex.org/W1999700717","https://openalex.org/W2001075505","https://openalex.org/W2013274571","https://openalex.org/W2025152196","https://openalex.org/W2028501030","https://openalex.org/W2035016250","https://openalex.org/W2041690090","https://openalex.org/W2052469602","https://openalex.org/W2070837551","https://openalex.org/W2073618542","https://openalex.org/W2092921112","https://openalex.org/W2102389579","https://openalex.org/W2134185318","https://openalex.org/W2134711807","https://openalex.org/W2135780456","https://openalex.org/W2135812251","https://openalex.org/W2139852500","https://openalex.org/W2144829410","https://openalex.org/W2152446053","https://openalex.org/W2156305087","https://openalex.org/W2157064933","https://openalex.org/W2289661106","https://openalex.org/W2329336071","https://openalex.org/W2497241389","https://openalex.org/W2565340265","https://openalex.org/W2569977786","https://openalex.org/W2575160648","https://openalex.org/W2592518050","https://openalex.org/W2605942834","https://openalex.org/W2789484532","https://openalex.org/W2898091943","https://openalex.org/W2951219679","https://openalex.org/W2985038974","https://openalex.org/W3030476832","https://openalex.org/W3116189748","https://openalex.org/W3127967490","https://openalex.org/W3167556772","https://openalex.org/W3173409805","https://openalex.org/W3185326806","https://openalex.org/W4229457728","https://openalex.org/W4283379578","https://openalex.org/W4308165701","https://openalex.org/W4310461604","https://openalex.org/W4382601497","https://openalex.org/W4382727584","https://openalex.org/W4384522480","https://openalex.org/W4385665882","https://openalex.org/W4390202535","https://openalex.org/W4399776293","https://openalex.org/W4400977691","https://openalex.org/W4402250376","https://openalex.org/W4404645660","https://openalex.org/W4408620136","https://openalex.org/W4409148639","https://openalex.org/W4410257819","https://openalex.org/W4410907062","https://openalex.org/W4414380609","https://openalex.org/W4414922567","https://openalex.org/W4416773903","https://openalex.org/W4417067668","https://openalex.org/W7119988617","https://openalex.org/W7128058311","https://openalex.org/W7131352778","https://openalex.org/W7131886539","https://openalex.org/W7133892406","https://openalex.org/W7151913820","https://openalex.org/W7161628243","https://openalex.org/W7213460716"],"related_works":["https://openalex.org/W1995017657","https://openalex.org/W4415504738","https://openalex.org/W2036387727","https://openalex.org/W107317442","https://openalex.org/W4406553047","https://openalex.org/W2059348990","https://openalex.org/W2061385106","https://openalex.org/W2502971339","https://openalex.org/W2192674214","https://openalex.org/W4410257819"],"abstract_inverted_index":{"Alzheimer's":[0,247],"disease":[1],"remains":[2],"without":[3],"a":[4,40,45,102,180],"widely":[5],"available":[6],"disease-modifying":[7],"treatment.Passive":[8],"immunization":[9,38,226],"with":[10,30,44],"monoclonal":[11],"antibodies":[12],"has":[13],"entered":[14,57],"clinical":[15,58,67,256],"practice":[16],"for":[17,87,210,269,281,317],"early":[18],"disease;":[19],"however,":[20],"it":[21],"is":[22,28,227],"costly,":[23],"requires":[24],"repeated":[25],"infusions,":[26],"and":[27,69,96,121,198,202,214,220,259,265,287,299,326,337,349],"associated":[29],"an":[31],"increased":[32],"risk":[33],"of":[34,73,99,117,132,175,275,296],"amyloid-related":[35],"imaging":[36],"abnormalities.Active":[37],"represents":[39],"less":[41],"expensive":[42],"alternative":[43],"more":[46],"sustained":[47],"immune":[48,104],"response.This":[49],"review":[50],"discusses":[51],"eleven":[52],"such":[53],"preparations":[54],"that":[55,112],"have":[56,125],"trials,":[59],"describing":[60],"their":[61,70],"design,":[62],"the":[63,74,81,84,97,110,115,118,129,133,211,276,311,314,323,332,344],"current":[64],"evidence":[65,284],"on":[66,285,313],"efficacy,":[68],"safety":[71,288],"profiles.Separation":[72],"B-cell":[75],"epitope":[76,135],"from":[77],"T-cell":[78,134],"epitopes,":[79],"shortening":[80],"antigen":[82],"below":[83],"length":[85],"required":[86],"presentation":[88],"by":[89,267,272,322,330],"major":[90],"histocompatibility":[91],"complex":[92],"class":[93],"II":[94],"molecules,":[95],"selection":[98,333],"adjuvants":[100],"favoring":[101],"Th2type":[103],"response":[105,213],"were":[106,151,165,223,246,279,303,320,328],"intended":[107],"to":[108,114,291,306],"avoid":[109],"meningoencephalitis":[111],"led":[113],"discontinuation":[116],"first":[119],"trial,":[120,257],"no":[122,338,350],"further":[123,282],"cases":[124],"been":[126],"reported,":[127],"although":[128,162],"causal":[130],"role":[131],"was":[136,179,189,200,289,334,342],"never":[137],"established.Vasogenic":[138],"edema":[139],"occurred":[140],"rarely":[141],"or":[142],"not":[143,193,335],"at":[144,152],"all,":[145],"while":[146,218],"microhemorrhages":[147],"in":[148,156,159,168,184,262,294,300,310],"several":[149],"trials":[150,186,292],"least":[153],"as":[154,158,231,234],"frequent":[155],"control":[157,163],"vaccinated":[160],"arms,":[161],"arms":[164],"small.Antibody":[166],"concentrations":[167],"cerebrospinal":[169],"fluid":[170],"reached":[171],"only":[172,305],"about":[173],"0.1%":[174],"serum":[176],"concentrations.Clinical":[177],"efficacy":[178,286],"prespecified":[181],"primary":[182],"endpoint":[183],"three":[185],"only;":[187],"one":[188,191,199],"halted,":[190],"did":[192],"reach":[194],"its":[195,207,215],"planned":[196],"duration,":[197],"completed":[201],"proved":[203],"negative.Each":[204],"study":[205],"used":[206,245],"own":[208,216],"threshold":[209],"serological":[212],"assay,":[217],"cognitive":[219],"volumetric":[221],"outcomes":[222],"predominantly":[224],"exploratory.Active":[225],"therefore":[228],"better":[229],"described":[230],"unproven":[232],"than":[233],"ineffective.":[235],"Keywords:":[236],"immunotherapy,":[237],"Alzheimer":[238],"disease,":[239,248],"tau":[240],"proteins,":[241],"amyloid":[242],"beta-peptidesThe":[243],"terms":[244],"dementia,":[249],"vaccine,":[250],"vaccination,":[251],"active":[252],"immunization,":[253],"amyloid-\u03b2,":[254],"tau,":[255],"immunogenicity":[258],"safety,":[260],"combined":[261],"varying":[263],"configurations":[264],"supplemented":[266],"searches":[268],"each":[270],"preparation":[271],"name.Reference":[273],"lists":[274],"retrieved":[277],"articles":[278],"screened":[280],"sources.Clinical":[283],"restricted":[290],"conducted":[293],"humans,":[295],"any":[297],"phase.Preclinical":[298],"vitro":[301],"studies":[302],"cited":[304],"illustrate":[307],"mechanisms,":[308],"principally":[309],"section":[312],"pathophysiological":[315],"basis":[316],"vaccine":[318],"development.Articles":[319],"selected":[321],"authors":[324],"jointly":[325],"disagreements":[327],"resolved":[329],"discussion.Because":[331],"exhaustive":[336],"formal":[339],"risk-of-bias":[340],"assessment":[341],"performed,":[343],"findings":[345],"are":[346,353],"presented":[347],"descriptively":[348],"pooled":[351],"estimates":[352],"reported.":[354]},"counts_by_year":[],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2026-10-29T00:00:00"}
