6. Study Design and Methodology
6.1 Design and Duration
This is a prospective longitudinal cohort study with follow up for 3 years.
6.2 Number of Subjects
Aim is to recruit a total of 150 subjects.
100 subjects with possible early Alzheimer’s Disease/ MCI
50 subjects with early onset neurodegeneration.
6.3 Sample Size
This is an exploratory study that aims to examine the utility of CSF biomarkers in the prediction of the conversion of MCI to AD and in the diagnosis of early onset neurodegeneration while at the same time contribute to the standardisation of the measurement of CSF biomarkers across Europe and to establish a clinical reference laboratory in Ireland for AD CSF biomarker assay. For a definitive study, very large numbers of CSF samples would be required and this would not be feasible and for this reason, a formal power analysis and sample size calculation is not applicable for this study.
6.4 Study Sites
Currently St. James hospital is the main site in the study however, there are collaborations with other clinicians supporting patient recruitment at other sites. If you are interested in collaborating and making a contribution to the project please contact Anne-Marie Miller, research project manager.
6.4.1 St James Hospital- Main Study Site
In St. James Hospital, active recruitment of participants will take place. Eligible subjects will be recruited through both ‘psychiatry of old age’ and ‘neurology’ and both specialties will collaborate closely. Lumber Punctures will be performed in the regular LP clinic run weekly by Neurology (Dr Siobhan Hutchinson, Consultant Neurologist). Participants will undergo cognitive testing in our Memory Clinic.
Mr. Garret Rochford (Research Assistant) will perform biomarker analysis in our central laboratory, SJH. Currently we are in the process of establishing a reference range for β- amyloid. P–tau and T-tau levels using Innotest Elisa Assays.
Our ultimate aim is to establish these assays as routine clinical tests available to clinicians in Ireland, as part of the diagnostic work-up for investigation of neurodegenerative diseases.
We also aim to establish a national biobank for blood and CSF samples in St James Hospital, to facilitate and promote future clinical research among Irish collaborators, in approaches to the harmonisation of patient sample documentation, collection, storage and analytical methods in the area of neurodegenerative diseases.
6.4.2 Collaborating study sites
Collaborating study sites in Ireland who agree to participate in this study can have all samples sent to our lab (Central Pathology Lab, St James Hospital) for biomarker analysis. For further information please contact Anne-Marie Miller, project manager.