Methods in clinical pharmacology
Reasons that prevent the inclusion of Alzheimer's disease patients in clinical trials
Version of Record online: 15 MAR 2013
© 2012 The Authors. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society
British Journal of Clinical Pharmacology
Volume 75, Issue 4, pages 1089–1097, April 2013
How to Cite
Rollin-Sillaire, A., Breuilh, L., Salleron, J., Bombois, S., Cassagnaud, P., Deramecourt, V., Mackowiak, M.-A. and Pasquier, F. (2013), Reasons that prevent the inclusion of Alzheimer's disease patients in clinical trials. British Journal of Clinical Pharmacology, 75: 1089–1097. doi: 10.1111/j.1365-2125.2012.04423.x
- Issue online: 15 MAR 2013
- Version of Record online: 15 MAR 2013
- Accepted manuscript online: 15 AUG 2012 04:00AM EST
- Manuscript Accepted: 10 AUG 2012
- Manuscript Received: 31 JAN 2012
- French National Alzheimer Plan
- Alzheimer's disease;
- clinical trial
To assess reasons that prevent Alzheimer's disease (AD) patients from being included in clinical trials.
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.
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%).
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.