Reasons that prevent the inclusion of Alzheimer's disease patients in clinical trials

Authors

  • Adeline Rollin-Sillaire,

    Corresponding author
    1. EA 1046, Excellence Laboratory DISTALZ, Memory Clinic, Lille University Hospital, Lille, France
    • Univ Lille Nord de France, UDSL, Lille, France
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  • Laetitia Breuilh,

    1. Univ Lille Nord de France, UDSL, Lille, France
    2. EA 1046, Excellence Laboratory DISTALZ, Memory Clinic, Lille University Hospital, Lille, France
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  • Julia Salleron,

    1. Univ Lille Nord de France, UDSL, Lille, France
    2. EA 2694 Department of Medical Statistics Lille University Hospital, Lille, France
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  • Stéphanie Bombois,

    1. Univ Lille Nord de France, UDSL, Lille, France
    2. EA 1046, Excellence Laboratory DISTALZ, Memory Clinic, Lille University Hospital, Lille, France
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  • Pascaline Cassagnaud,

    1. Univ Lille Nord de France, UDSL, Lille, France
    2. EA 1046, Excellence Laboratory DISTALZ, Memory Clinic, Lille University Hospital, Lille, France
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  • Vincent Deramecourt,

    1. Univ Lille Nord de France, UDSL, Lille, France
    2. EA 1046, Excellence Laboratory DISTALZ, Memory Clinic, Lille University Hospital, Lille, France
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  • Marie-Anne Mackowiak,

    1. Univ Lille Nord de France, UDSL, Lille, France
    2. EA 1046, Excellence Laboratory DISTALZ, Memory Clinic, Lille University Hospital, Lille, France
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  • Florence Pasquier

    1. Univ Lille Nord de France, UDSL, Lille, France
    2. EA 1046, Excellence Laboratory DISTALZ, Memory Clinic, Lille University Hospital, Lille, France
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Correspondence

Dr Adeline Rollin-Sillaire, MD, Centre Mémoire de Ressources et de Recherche, Centre Hospitalier Régional et Universitaire de Lille, Rue du Professeur Emile Laine, F-59037 Lille cedex, France.

Tel.: +333 2044 6021

Fax: +333 2044 6022

E-mail: adeline.rollin@chru-lille.fr

Abstract

Aim

To assess reasons that prevent Alzheimer's disease (AD) patients from being included in clinical trials.

Methods

In 2009, we reviewed the Lille Memory Clinic'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 Memory Clinic. 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.

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