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Reasons that prevent the inclusion of A lzheimer's disease patients in clinical trials
Author(s) -
RollinSillaire Adeline,
Breuilh Laetitia,
Salleron Julia,
Bombois Stéphanie,
Cassagnaud Pascaline,
Deramecourt Vincent,
Mackowiak MarieAnne,
Pasquier Florence
Publication year - 2013
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/j.1365-2125.2012.04423.x
Subject(s) - medicine , clinical trial , contraindication , disease , inclusion and exclusion criteria , hyperintensity , memantine , inclusion (mineral) , pediatrics , dementia , pathology , magnetic resonance imaging , psychology , alternative medicine , radiology , social psychology
Aim To assess reasons that prevent A lzheimer's disease ( AD ) patients from being included in clinical trials. Methods In 2009, we reviewed the L ille M emory C linic's case database to identify patients suitable for inclusion in four AD clinical trials. An initial selection was made on the basis of four criteria: (i) a diagnosis of AD (with or without white matter lesions [ WML ]), (ii) age, (iii) mini mental state examination ( MMSE ) score and (iv) symptomatic treatment of AD (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 emory C linic. Reasons for non‐inclusion were analyzed. Results 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 (56.9%, 88.9% of which were WML ), unauthorized medication (37.3%), the lack of a study partner/informant (37.1%), the presence of a non‐authorized disease (24.4%), contraindication to MRI (9%), a change in diagnosis over time (3.9%), visual/auditory impairments (2.9%), alcohol abuse (2%) and an insufficient educational level (1%). Conclusion A high proportion of AD patients presented with vascular abnormalities on MRI . 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 . 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.