Mibampator (LY451395) randomized clinical trial for agitation/aggression in Alzheimer's disease
Background: Mibampator, an amino-3-hydroxy-5-methyl-4-isoxazole propionic acid receptor potentiator, was evaluated for treatment of agitation and aggression (A/A) in Alzheimer's disease (AD). Methods: Outpatients (n = 132) with probable AD and A/A randomized to 12 weeks of double-blind treatmen...
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| Veröffentlicht in: | International psychogeriatrics 2013-05, Vol.25 (5), p.707-719 |
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| creator | Trzepacz, Paula T. Cummings, Jeffrey Konechnik, Thomas Forrester, Tammy D. Chang, Curtis Dennehy, Ellen B. Willis, Brian A. Shuler, Catherine Tabas, Linda B. Lyketsos, Constantine |
| description | Background: Mibampator, an amino-3-hydroxy-5-methyl-4-isoxazole propionic acid receptor potentiator, was evaluated for treatment of agitation and aggression (A/A) in Alzheimer's disease (AD). Methods: Outpatients (n = 132) with probable AD and A/A randomized to 12 weeks of double-blind treatment with 3-mg po mibampator or placebo were assessed using the 4-domain A/A subscale of the Neuropsychiatric Inventory (NPI-4-A/A) derived from the Neuropsychiatric Inventory. Secondary measures included the Cohen-Mansfield Agitation Inventory, Cornell Scale for Depression in Dementia, Frontal Systems Behavior Inventory (FrSBe), and Alzheimer's Disease Assessment Scale-Cognitive. Efficacy was analyzed using mixed-effects model repeated measures from baseline to endpoint. Adverse events (AEs), labs, vital signs, and electrocardiograms were monitored. Results: Baseline characteristics were comparable between groups. Both groups improved on the NPI-4-A/A, but without group differences. Among secondaries, mibampator was significantly better (p = 0.007) than placebo only on the FrSBe. AEs were similar between groups. One death occurred in the placebo group. Conclusion: Possible explanations for no significant group differences include caregiver, drug target engagement, and design issues. This trial is registered on ClinicalTrials.gov; ID: NCT00843518. |
| doi_str_mv | 10.1017/S1041610212002141 |
| format | Article |
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Methods: Outpatients (n = 132) with probable AD and A/A randomized to 12 weeks of double-blind treatment with 3-mg po mibampator or placebo were assessed using the 4-domain A/A subscale of the Neuropsychiatric Inventory (NPI-4-A/A) derived from the Neuropsychiatric Inventory. Secondary measures included the Cohen-Mansfield Agitation Inventory, Cornell Scale for Depression in Dementia, Frontal Systems Behavior Inventory (FrSBe), and Alzheimer's Disease Assessment Scale-Cognitive. Efficacy was analyzed using mixed-effects model repeated measures from baseline to endpoint. Adverse events (AEs), labs, vital signs, and electrocardiograms were monitored. Results: Baseline characteristics were comparable between groups. Both groups improved on the NPI-4-A/A, but without group differences. Among secondaries, mibampator was significantly better (p = 0.007) than placebo only on the FrSBe. AEs were similar between groups. One death occurred in the placebo group. Conclusion: Possible explanations for no significant group differences include caregiver, drug target engagement, and design issues. This trial is registered on ClinicalTrials.gov; ID: NCT00843518.</description><identifier>ISSN: 1041-6102</identifier><identifier>EISSN: 1741-203X</identifier><identifier>DOI: 10.1017/S1041610212002141</identifier><identifier>PMID: 23257314</identifier><language>eng</language><publisher>Cambridge, UK: Cambridge University Press</publisher><subject>Adult and adolescent clinical studies ; Aged ; Aged, 80 and over ; aggression ; Aggression - drug effects ; Aggression - psychology ; agitation ; Alzheimer Disease - complications ; Alzheimer Disease - drug therapy ; Alzheimer Disease - psychology ; Alzheimer's disease ; AMPA ; Biological and medical sciences ; Biphenyl Compounds - pharmacology ; Biphenyl Compounds - therapeutic use ; Clinical outcomes ; Clinical trials ; Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases ; Double-Blind Method ; Drug therapy ; Female ; Geriatric psychology ; Geriatrics ; glutamate ; Humans ; Male ; Medical sciences ; mibampator ; Middle Aged ; Neurology ; Neuropsychiatric Inventory ; neuropsychiatric symptoms ; Neuropsychological Tests ; Older people ; Organic mental disorders. Neuropsychology ; Outpatients ; Psychology. Psychoanalysis. Psychiatry ; Psychomotor Agitation - drug therapy ; Psychomotor Agitation - etiology ; Psychomotor Agitation - psychology ; Psychopathology. Psychiatry ; Sulfonamides - pharmacology ; Sulfonamides - therapeutic use ; Surveys and Questionnaires ; Treatment Outcome</subject><ispartof>International psychogeriatrics, 2013-05, Vol.25 (5), p.707-719</ispartof><rights>Copyright © International Psychogeriatric Association 2012</rights><rights>2012 Copyright © International Psychogeriatric Association 2012</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c652t-3086dea3e19e68abd32fad8040ee086de6a8fc057ee10dfd05abf1edb2b388103</citedby><cites>FETCH-LOGICAL-c652t-3086dea3e19e68abd32fad8040ee086de6a8fc057ee10dfd05abf1edb2b388103</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.cambridge.org/core/product/identifier/S1041610212002141/type/journal_article$$EHTML$$P50$$Gcambridge$$H</linktohtml><link.rule.ids>164,230,314,778,782,883,12829,27907,27908,30982,55611</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27250675$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23257314$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Trzepacz, Paula T.</creatorcontrib><creatorcontrib>Cummings, Jeffrey</creatorcontrib><creatorcontrib>Konechnik, Thomas</creatorcontrib><creatorcontrib>Forrester, Tammy D.</creatorcontrib><creatorcontrib>Chang, Curtis</creatorcontrib><creatorcontrib>Dennehy, Ellen B.</creatorcontrib><creatorcontrib>Willis, Brian A.</creatorcontrib><creatorcontrib>Shuler, Catherine</creatorcontrib><creatorcontrib>Tabas, Linda B.</creatorcontrib><creatorcontrib>Lyketsos, Constantine</creatorcontrib><title>Mibampator (LY451395) randomized clinical trial for agitation/aggression in Alzheimer's disease</title><title>International psychogeriatrics</title><addtitle>Int. Psychogeriatr</addtitle><description>Background: Mibampator, an amino-3-hydroxy-5-methyl-4-isoxazole propionic acid receptor potentiator, was evaluated for treatment of agitation and aggression (A/A) in Alzheimer's disease (AD). Methods: Outpatients (n = 132) with probable AD and A/A randomized to 12 weeks of double-blind treatment with 3-mg po mibampator or placebo were assessed using the 4-domain A/A subscale of the Neuropsychiatric Inventory (NPI-4-A/A) derived from the Neuropsychiatric Inventory. Secondary measures included the Cohen-Mansfield Agitation Inventory, Cornell Scale for Depression in Dementia, Frontal Systems Behavior Inventory (FrSBe), and Alzheimer's Disease Assessment Scale-Cognitive. Efficacy was analyzed using mixed-effects model repeated measures from baseline to endpoint. Adverse events (AEs), labs, vital signs, and electrocardiograms were monitored. Results: Baseline characteristics were comparable between groups. Both groups improved on the NPI-4-A/A, but without group differences. Among secondaries, mibampator was significantly better (p = 0.007) than placebo only on the FrSBe. AEs were similar between groups. One death occurred in the placebo group. Conclusion: Possible explanations for no significant group differences include caregiver, drug target engagement, and design issues. This trial is registered on ClinicalTrials.gov; ID: NCT00843518.</description><subject>Adult and adolescent clinical studies</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>aggression</subject><subject>Aggression - drug effects</subject><subject>Aggression - psychology</subject><subject>agitation</subject><subject>Alzheimer Disease - complications</subject><subject>Alzheimer Disease - drug therapy</subject><subject>Alzheimer Disease - psychology</subject><subject>Alzheimer's disease</subject><subject>AMPA</subject><subject>Biological and medical sciences</subject><subject>Biphenyl Compounds - pharmacology</subject><subject>Biphenyl Compounds - therapeutic use</subject><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Geriatric psychology</subject><subject>Geriatrics</subject><subject>glutamate</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>mibampator</subject><subject>Middle Aged</subject><subject>Neurology</subject><subject>Neuropsychiatric Inventory</subject><subject>neuropsychiatric symptoms</subject><subject>Neuropsychological Tests</subject><subject>Older people</subject><subject>Organic mental disorders. Neuropsychology</subject><subject>Outpatients</subject><subject>Psychology. Psychoanalysis. Psychiatry</subject><subject>Psychomotor Agitation - drug therapy</subject><subject>Psychomotor Agitation - etiology</subject><subject>Psychomotor Agitation - psychology</subject><subject>Psychopathology. Psychiatry</subject><subject>Sulfonamides - pharmacology</subject><subject>Sulfonamides - therapeutic use</subject><subject>Surveys and Questionnaires</subject><subject>Treatment Outcome</subject><issn>1041-6102</issn><issn>1741-203X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>7QJ</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqNkU2L1EAQhoMo7of-AC8SENn1ELcrnU46CMKy-AUjHlTQU1PprszWkqTH7syC--vtccZ1VRQvVQXvU0VVvVn2AMRTENCcvAdRQQ2ihFKkUMGtbB-aCopSyE-3U53kYqPvZQcxXiRGSajuZnulLFWTyv3MvOUOxxXOPuTHi8-VAtmqJ3nAyfmRr8jlduCJLQ75HDjFPoG45Bln9tMJLpeBYkxlzlN-OlydE48UjmLuOBJGupfd6XGIdH-XD7OPL198OHtdLN69enN2uihsrcq5kELXjlAStFRr7Jwse3RaVILou1Sj7q1QDREI1zuhsOuBXFd2UmsQ8jB7vp27WncjOUvTHHAwq8Ajhq_GI5tflYnPzdJfGtlKXQuZBhzvBgT_ZU1xNiNHS8OAE_l1NOm7rax1-z-ohBZ0U8kmoY9-Qy_8OkzpExtKK9VCqxMFW8oGH2Og_npvEGbjtPnD6dTz8ObB1x0_rE3A4x2AMdnXJ0stx59cUypRNypxz7YcJXsumYKJlmmy5DiQnY3z_M815G51HLvAbkk3Lvxr1zfiV9HA</recordid><startdate>20130501</startdate><enddate>20130501</enddate><creator>Trzepacz, Paula T.</creator><creator>Cummings, Jeffrey</creator><creator>Konechnik, Thomas</creator><creator>Forrester, Tammy D.</creator><creator>Chang, Curtis</creator><creator>Dennehy, Ellen B.</creator><creator>Willis, Brian A.</creator><creator>Shuler, Catherine</creator><creator>Tabas, Linda B.</creator><creator>Lyketsos, Constantine</creator><general>Cambridge University Press</general><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0-V</scope><scope>3V.</scope><scope>7QJ</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>88J</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ALSLI</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HEHIP</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>M2O</scope><scope>M2R</scope><scope>M2S</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>7TK</scope><scope>5PM</scope></search><sort><creationdate>20130501</creationdate><title>Mibampator (LY451395) randomized clinical trial for agitation/aggression in Alzheimer's disease</title><author>Trzepacz, Paula T. ; Cummings, Jeffrey ; Konechnik, Thomas ; Forrester, Tammy D. ; Chang, Curtis ; Dennehy, Ellen B. ; Willis, Brian A. ; Shuler, Catherine ; Tabas, Linda B. ; Lyketsos, Constantine</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c652t-3086dea3e19e68abd32fad8040ee086de6a8fc057ee10dfd05abf1edb2b388103</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult and adolescent clinical studies</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>aggression</topic><topic>Aggression - drug effects</topic><topic>Aggression - psychology</topic><topic>agitation</topic><topic>Alzheimer Disease - complications</topic><topic>Alzheimer Disease - drug therapy</topic><topic>Alzheimer Disease - psychology</topic><topic>Alzheimer's disease</topic><topic>AMPA</topic><topic>Biological and medical sciences</topic><topic>Biphenyl Compounds - pharmacology</topic><topic>Biphenyl Compounds - therapeutic use</topic><topic>Clinical outcomes</topic><topic>Clinical trials</topic><topic>Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Female</topic><topic>Geriatric psychology</topic><topic>Geriatrics</topic><topic>glutamate</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>mibampator</topic><topic>Middle Aged</topic><topic>Neurology</topic><topic>Neuropsychiatric Inventory</topic><topic>neuropsychiatric symptoms</topic><topic>Neuropsychological Tests</topic><topic>Older people</topic><topic>Organic mental disorders. Neuropsychology</topic><topic>Outpatients</topic><topic>Psychology. Psychoanalysis. Psychiatry</topic><topic>Psychomotor Agitation - drug therapy</topic><topic>Psychomotor Agitation - etiology</topic><topic>Psychomotor Agitation - psychology</topic><topic>Psychopathology. Psychiatry</topic><topic>Sulfonamides - pharmacology</topic><topic>Sulfonamides - therapeutic use</topic><topic>Surveys and Questionnaires</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Trzepacz, Paula T.</creatorcontrib><creatorcontrib>Cummings, Jeffrey</creatorcontrib><creatorcontrib>Konechnik, Thomas</creatorcontrib><creatorcontrib>Forrester, Tammy D.</creatorcontrib><creatorcontrib>Chang, Curtis</creatorcontrib><creatorcontrib>Dennehy, Ellen B.</creatorcontrib><creatorcontrib>Willis, Brian A.</creatorcontrib><creatorcontrib>Shuler, Catherine</creatorcontrib><creatorcontrib>Tabas, Linda B.</creatorcontrib><creatorcontrib>Lyketsos, Constantine</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Social Sciences Premium Collection</collection><collection>ProQuest Central (Corporate)</collection><collection>Applied Social Sciences Index & Abstracts (ASSIA)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Social Science Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>Social Science Premium Collection</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>Sociology Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Research Library</collection><collection>Social Science Database</collection><collection>Sociology Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>Neurosciences Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>International psychogeriatrics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Trzepacz, Paula T.</au><au>Cummings, Jeffrey</au><au>Konechnik, Thomas</au><au>Forrester, Tammy D.</au><au>Chang, Curtis</au><au>Dennehy, Ellen B.</au><au>Willis, Brian A.</au><au>Shuler, Catherine</au><au>Tabas, Linda B.</au><au>Lyketsos, Constantine</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Mibampator (LY451395) randomized clinical trial for agitation/aggression in Alzheimer's disease</atitle><jtitle>International psychogeriatrics</jtitle><addtitle>Int. Psychogeriatr</addtitle><date>2013-05-01</date><risdate>2013</risdate><volume>25</volume><issue>5</issue><spage>707</spage><epage>719</epage><pages>707-719</pages><issn>1041-6102</issn><eissn>1741-203X</eissn><abstract>Background: Mibampator, an amino-3-hydroxy-5-methyl-4-isoxazole propionic acid receptor potentiator, was evaluated for treatment of agitation and aggression (A/A) in Alzheimer's disease (AD). Methods: Outpatients (n = 132) with probable AD and A/A randomized to 12 weeks of double-blind treatment with 3-mg po mibampator or placebo were assessed using the 4-domain A/A subscale of the Neuropsychiatric Inventory (NPI-4-A/A) derived from the Neuropsychiatric Inventory. Secondary measures included the Cohen-Mansfield Agitation Inventory, Cornell Scale for Depression in Dementia, Frontal Systems Behavior Inventory (FrSBe), and Alzheimer's Disease Assessment Scale-Cognitive. Efficacy was analyzed using mixed-effects model repeated measures from baseline to endpoint. Adverse events (AEs), labs, vital signs, and electrocardiograms were monitored. Results: Baseline characteristics were comparable between groups. Both groups improved on the NPI-4-A/A, but without group differences. Among secondaries, mibampator was significantly better (p = 0.007) than placebo only on the FrSBe. AEs were similar between groups. One death occurred in the placebo group. Conclusion: Possible explanations for no significant group differences include caregiver, drug target engagement, and design issues. This trial is registered on ClinicalTrials.gov; ID: NCT00843518.</abstract><cop>Cambridge, UK</cop><pub>Cambridge University Press</pub><pmid>23257314</pmid><doi>10.1017/S1041610212002141</doi><tpages>13</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | International psychogeriatrics, 2013-05, Vol.25 (5), p.707-719 |
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| subjects | Adult and adolescent clinical studies Aged Aged, 80 and over aggression Aggression - drug effects Aggression - psychology agitation Alzheimer Disease - complications Alzheimer Disease - drug therapy Alzheimer Disease - psychology Alzheimer's disease AMPA Biological and medical sciences Biphenyl Compounds - pharmacology Biphenyl Compounds - therapeutic use Clinical outcomes Clinical trials Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases Double-Blind Method Drug therapy Female Geriatric psychology Geriatrics glutamate Humans Male Medical sciences mibampator Middle Aged Neurology Neuropsychiatric Inventory neuropsychiatric symptoms Neuropsychological Tests Older people Organic mental disorders. Neuropsychology Outpatients Psychology. Psychoanalysis. Psychiatry Psychomotor Agitation - drug therapy Psychomotor Agitation - etiology Psychomotor Agitation - psychology Psychopathology. Psychiatry Sulfonamides - pharmacology Sulfonamides - therapeutic use Surveys and Questionnaires Treatment Outcome |
| title | Mibampator (LY451395) randomized clinical trial for agitation/aggression in Alzheimer's disease |
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