{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T15:13:02Z","timestamp":1780585982548,"version":"3.54.1"},"reference-count":22,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2013,3,15]],"date-time":"2013-03-15T00:00:00Z","timestamp":1363305600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2013,4]]},"abstract":"Aim<\/jats:title>To assess reasons that prevent A<\/jats:styled-content>lzheimer's disease (AD<\/jats:styled-content>) patients from being included in clinical trials.<\/jats:p><\/jats:sec>Methods<\/jats:title>In 2009, we reviewed the L<\/jats:styled-content>ille M<\/jats:styled-content>emory C<\/jats:styled-content>linic's case database to identify patients suitable for inclusion in four AD<\/jats:styled-content> clinical trials. An initial selection was made on the basis of four criteria: (i) a diagnosis of AD<\/jats:styled-content> (with or without white matter lesions [WML<\/jats:styled-content>]), (ii) age, (iii) mini mental state examination (MMSE<\/jats:styled-content>) score and (iv) symptomatic treatment of AD<\/jats:styled-content> (cholinesterase inhibitors\/memantine). Next, data on patients fulfilling these criteria were reviewed against all the inclusion\/exclusion criteria for four clinical trials performed in 2009 at the M<\/jats:styled-content>emory C<\/jats:styled-content>linic. Reasons for non\u2010inclusion were analyzed.<\/jats:p><\/jats:sec>Results<\/jats:title>Two hundred and five patients were selected according to the four initial criteria. Reasons for subsequently not including some of patients in clinical trials were abnormalities on MRI<\/jats:styled-content> (56.9%, 88.9% of which were WML<\/jats:styled-content>), unauthorized medication (37.3%), the lack of a study partner\/informant (37.1%), the presence of a non\u2010authorized disease (24.4%), contraindication to MRI<\/jats:styled-content> (9%), a change in diagnosis over time (3.9%), visual\/auditory impairments (2.9%), alcohol abuse (2%) and an insufficient educational level (1%).<\/jats:p><\/jats:sec>Conclusion<\/jats:title>A high proportion of AD<\/jats:styled-content> patients presented with vascular abnormalities on MRI<\/jats:styled-content>. This was not unexpected, since the patients were selected from the database and, as shown in epidemiologic studies, cerebrovascular diseases are frequently associated with AD<\/jats:styled-content>. The presence of a study partner is essential for enabling a patient to participate in clinical trials because of the need to record reliably primary and secondary outcomes.<\/jats:p><\/jats:sec>","DOI":"10.1111\/j.1365-2125.2012.04423.x","type":"journal-article","created":{"date-parts":[[2012,8,15]],"date-time":"2012-08-15T09:15:21Z","timestamp":1345022121000},"page":"1089-1097","source":"Crossref","is-referenced-by-count":28,"title":["Reasons that prevent the inclusion of A<\/scp>lzheimer's disease patients in clinical trials"],"prefix":"10.1111","volume":"75","author":[{"given":"Adeline","family":"Rollin\u2010Sillaire","sequence":"first","affiliation":[{"name":"Univ Lille Nord de France UDSL Lille France"},{"name":"EA 1046, Excellence Laboratory DISTALZ, Memory Clinic, Lille University Hospital Lille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laetitia","family":"Breuilh","sequence":"additional","affiliation":[{"name":"Univ Lille Nord de France UDSL Lille France"},{"name":"EA 1046, Excellence Laboratory DISTALZ, Memory Clinic, Lille University Hospital Lille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Salleron","sequence":"additional","affiliation":[{"name":"Univ Lille Nord de France UDSL Lille France"},{"name":"EA 2694 Department of Medical Statistics Lille University Hospital Lille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"St\u00e9phanie","family":"Bombois","sequence":"additional","affiliation":[{"name":"Univ Lille Nord de France UDSL Lille France"},{"name":"EA 1046, Excellence Laboratory DISTALZ, Memory Clinic, Lille University Hospital Lille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pascaline","family":"Cassagnaud","sequence":"additional","affiliation":[{"name":"Univ Lille Nord de France UDSL Lille France"},{"name":"EA 1046, Excellence Laboratory DISTALZ, Memory Clinic, Lille University Hospital Lille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincent","family":"Deramecourt","sequence":"additional","affiliation":[{"name":"Univ Lille Nord de France UDSL Lille France"},{"name":"EA 1046, Excellence Laboratory DISTALZ, Memory Clinic, Lille University Hospital Lille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie\u2010Anne","family":"Mackowiak","sequence":"additional","affiliation":[{"name":"Univ Lille Nord de France UDSL Lille France"},{"name":"EA 1046, Excellence Laboratory DISTALZ, Memory Clinic, Lille University Hospital Lille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florence","family":"Pasquier","sequence":"additional","affiliation":[{"name":"Univ Lille Nord de France UDSL Lille France"},{"name":"EA 1046, Excellence Laboratory DISTALZ, Memory Clinic, Lille University Hospital Lille France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2013,3,15]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)67889-0"},{"issue":"8","key":"e_1_2_9_3_1","first-page":"S43","article-title":"Recruitment of subjects into clinical trials for Alzheimer disease","volume":"110","author":"Knebl JA","year":"2010","journal-title":"J Am Osteopath Assoc"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/WAD.0b013e3181461740"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.wad.0000190808.97878.b8"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000336652.05779.ea"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.34.7.939"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(74)91496-2"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e3181b59bf3"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp.2007.137851"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/WNN.0b013e318190cf75"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.2214\/ajr.149.2.351"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.STR.32.6.1318"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/awn261"},{"key":"e_1_2_9_15_1","unstructured":"Guideline on medicinal products for the treatment of Alzheimer's disease and other dementias.2008. 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