FACEHBI: A PROSPECTIVE STUDY OF RISK FACTORS, BIOMARKERS AND COGNITION IN A COHORT OF INDIVIDUALS WITH SUBJECTIVE COGNITIVE DECLINE. STUDY RATIONALE AND RESEARCH PROTOCOLS
O. Rodriguez-Gomez, A. Sanabria, A. Perez-Cordon, D. Sanchez-Ruiz, C. Abdelnour, S. Valero, I. Hernandez, M. Rosende-Roca, A. Mauleon, L. Vargas, M. Alegret, A. Espinosa, G. Ortega, M. Guitart, A. Gailhajanet, O. Sotolongo-Grau, S. Moreno-Grau, S. Ruiz, M. Tarragona, J. Serra, E. Martin, E. Peleja, F. Lomeña, F. Campos, A. Vivas, M.Gomez-Chiari, M.A. Tejero, J. Giménez, P. Pesini, M. Sarasa, G.Martinez, A. Ruiz, L. Tarraga, M.Boada
J Prev Alz Dis 2017;4(2):100-108
Background: Long-term longitudinal studies with multimodal biomarkers are needed to delve into the knowledge of preclinical AD. Subjective cognitive decline has been proposed as a risk factor for the development of cognitive impairment. Thus, including individuals with SCD in observational studies may be a cost-effective strategy to increase the prevalence of preclinical AD in the sample.
Objectives: To describe the rationale, research protocols and baseline characteristics of participants in the Fundació ACE Healthy Brain Initiative (FACEHBI).
Design: FACEHBI is a clinical trial (EudraCT: 2014-000798-38) embedded within a long-term observational study of individuals with SCD.
Setting: Participants have been recruited at the memory clinic of Fundació ACE (Barcelona) from two different sources: patients referred by a general practitioner and individuals from an Open House Initiative.
Participants: 200 individuals diagnosed with SCD with a strictly normal performance in a comprehensive neuropsychological battery.
Measurements: Individuals will undergo an extensive neuropsychological protocol, risk factor assessment and a set of multimodal biomarkers including florbetaben PET, structural and functional MRI, diffusion tensor imaging, determination of amyloid species in plasma and neurophthalmologic assessment with optical coherence tomography.
Results: Two hundred individuals have been recruited in 15 months. Mean age was 65.9 years; mean MMSE was 29.2 with a mean of 14.8 years of education.
Conclusions: FACEHBI is a long-term study of cognition, biomarkers and lifestyle that has been designed upon an innovative symptom-based approach using SCD as target population. It will shed light on the pathophysiology of preclinical AD and the role of SCD as a risk marker for the development of cognitive impairment.
O. Rodriguez-Gomez ; A. Sanabria ; A. Perez-Cordon ; D. Sanchez-Ruiz ; C. Abdelnour ; S. Valero ; I. Hernandez ; M. Rosende-Roca ; A. Mauleon ; L. Vargas ; M. Alegret ; A. Espinosa ; G. Ortega ; M. Guitart ; A. Gailhajanet ; O. Sotolongo-Grau ; S. Moreno-Grau ; S. Ruiz ; M. Tarragona ; J. Serra ; E. Martin ; E. Peleja ; F. Lomeña ; F. Campos ; A. Vivas ; M.Gomez-Chiari ; M.A. Tejero ; J. Giménez ; P. Pesini ; M. Sarasa ; G.Martinez ; A. Ruiz ; L. Tarraga ; M. Boada (2016): FACEHBI: A Prospective Study of Risk Factors, Biomarkers and Cognition in a Cohort of Individuals with Subjective Cognitive Decline. Study Rationale and Research Protocols. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2016.122