Affiliations: [a] University of Tasmania, Hobart, Tasmania, Australia
| [b] Ethics, Policy & Public Engagement (EPPE) Program, Australian Research Council Centre of Excellence for Electromaterials Science, Hobart, Tasmania, Australia
| [c] Charité - Universitätsmedizin Berlin, Berlin, Germany
Correspondence:
[*]
Correspondence to: John Noel M. Viaña, MSc, University of Tasmania, Private Bag 41, Hobart, Tasmania 7001, Australia. Tel.: +61 432741133; E-mail: [email protected].
Abstract: Several studies of deep brain stimulation (DBS) of the fornix or the nucleus basalis of Meynert have been recently conducted in people with Alzheimer’s disease, with several recruiting participants <65 and thus have early-onset Alzheimer’s disease (EOAD). Although EOAD accounts for less than 5.5% of AD cases, ethical considerations must still be made when performing DBS trials including these participants since a portion of people with EOAD, especially those possessing autosomal-dominant mutations, have an atypical and more aggressive disease progression. These considerations include appropriate patient selection and signing of an informed consent for genetic testing; appropriate study design; potential outcomes that people with EOAD could expect; and accurate interpretation and balanced discussion of trial results. Finally, recommendations for future DBS for AD trials will be made to ensure that EOAD patients will not experience avoidable harms should they be enrolled in these experimental studies.
Keywords: Clinical trials as topic, deep brain stimulation, early onset Alzheimer’s disease, ethical review, ethics, familial Alzheimer’s disease, fornix (brain), nucleus basalis of Meynert
