ENGAGE and EMERGE: Truth and consequences?
The potential benefit of the anti‐amyloid drug aducanumab based on results of recent EMERGE and ENGAGE clinical trials has generated great controversy and has very important implications for the future of anti‐amyloid drug therapies. The two trials of 18‐month duration were done in patients with mil...
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| Veröffentlicht in: | Alzheimer's & dementia 2021-04, Vol.17 (4), p.692-695 |
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| creator | Kuller, Lewis H. Lopez, Oscar L. |
| description | The potential benefit of the anti‐amyloid drug aducanumab based on results of recent EMERGE and ENGAGE clinical trials has generated great controversy and has very important implications for the future of anti‐amyloid drug therapies. The two trials of 18‐month duration were done in patients with mild cognitive impairment (MCI) and early dementia. The ENGAGE trial showed no benefit while the high‐dose EMERGE trial initially also showed no benefit but with longer follow‐up there was a significant positive benefit. A recent review form the U.S. Food and Drug Administration (FDA) Advisory Committee was negative while the FDA Office of Neurological Drugs was positive and the statisticians negative. This has generated debate about whether the drug should be approved, disapproved, require a new clinical trial, or approved for a subsample only. The implications for treating both MCI and Alzheimer's disease (AD) patients with anti‐amyloid drugs is very substantial as well as the brain amyloid‐AD‐dementia hypothesis. |
| doi_str_mv | 10.1002/alz.12286 |
| format | Article |
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The implications for treating both MCI and Alzheimer's disease (AD) patients with anti‐amyloid drugs is very substantial as well as the brain amyloid‐AD‐dementia hypothesis.</description><subject>aducanumab</subject><subject>Aged</subject><subject>Alzheimer Disease - drug therapy</subject><subject>Alzheimer's disease</subject><subject>Amyloid</subject><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>Biomarkers</subject><subject>clinical trials</subject><subject>Cognitive Dysfunction - drug therapy</subject><subject>dementia</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Approval</subject><subject>Food and Drug Administration</subject><subject>Humans</subject><subject>Policy Forum</subject><subject>Treatment Outcome</subject><issn>1552-5260</issn><issn>1552-5279</issn><issn>1552-5279</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp1kM9LwzAUx4Mobk4P_gOyowrd8qNJEw9KGbUKU0HmxUtI0sxVunYmqzL_eus6hx48vcd7Hz7v8QXgGMEBghAPVfE5QBhztgO6iFIcUByJ3W3PYAcceP8KYQg5ovugQwijDHPeBefJfRqnSV-VWT-5Sx7T5KI_cfVytp6YqvT2rbalsf7qEOxNVeHt0ab2wNN1MhndBOOH9HYUjwMTcsSCKGPEYEY0Nja0ltApyzKrCVaCIJMZxkKltTZCoAgypJkgykCEdMY4EpEiPXDZehe1ntvM2HLpVCEXLp8rt5KVyuXfTZnP5Ev1LjkOOaSiEZxuBK5qnvdLOc-9sUWhSlvVXuJQMEwhobhBz1rUuMp7Z6fbMwjK72xlk61cZ9uwJ7__2pI_YTbAsAU-8sKu_jfJePzcKr8AYn6Buw</recordid><startdate>202104</startdate><enddate>202104</enddate><creator>Kuller, Lewis H.</creator><creator>Lopez, Oscar L.</creator><general>John Wiley and Sons Inc</general><scope>24P</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>7X8</scope><scope>5PM</scope></search><sort><creationdate>202104</creationdate><title>ENGAGE and EMERGE: Truth and consequences?</title><author>Kuller, Lewis H. ; Lopez, Oscar L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4816-7d63c263b2ce4ee35f6ddeb32a931cdc664abbbc9917061b693ac011bd68197a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>aducanumab</topic><topic>Aged</topic><topic>Alzheimer Disease - drug therapy</topic><topic>Alzheimer's disease</topic><topic>Amyloid</topic><topic>Antibodies, Monoclonal, Humanized - therapeutic use</topic><topic>Biomarkers</topic><topic>clinical trials</topic><topic>Cognitive Dysfunction - drug therapy</topic><topic>dementia</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Approval</topic><topic>Food and Drug Administration</topic><topic>Humans</topic><topic>Policy Forum</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kuller, Lewis H.</creatorcontrib><creatorcontrib>Lopez, Oscar L.</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Alzheimer's & dementia</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kuller, Lewis H.</au><au>Lopez, Oscar L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>ENGAGE and EMERGE: Truth and consequences?</atitle><jtitle>Alzheimer's & dementia</jtitle><addtitle>Alzheimers Dement</addtitle><date>2021-04</date><risdate>2021</risdate><volume>17</volume><issue>4</issue><spage>692</spage><epage>695</epage><pages>692-695</pages><issn>1552-5260</issn><issn>1552-5279</issn><eissn>1552-5279</eissn><abstract>The potential benefit of the anti‐amyloid drug aducanumab based on results of recent EMERGE and ENGAGE clinical trials has generated great controversy and has very important implications for the future of anti‐amyloid drug therapies. 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| ispartof | Alzheimer's & dementia, 2021-04, Vol.17 (4), p.692-695 |
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| language | eng |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | aducanumab Aged Alzheimer Disease - drug therapy Alzheimer's disease Amyloid Antibodies, Monoclonal, Humanized - therapeutic use Biomarkers clinical trials Cognitive Dysfunction - drug therapy dementia Dose-Response Relationship, Drug Drug Approval Food and Drug Administration Humans Policy Forum Treatment Outcome |
| title | ENGAGE and EMERGE: Truth and consequences? |
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