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J Prev Alzheimers Dis. 2017;4(2):100-108. doi: 10.14283/jpad.2016.122.

FACEHBI: A Prospective Study of Risk Factors, Biomarkers and Cognition in a Cohort of Individuals with Subjective Cognitive Decline. Study Rationale and Research Protocols.

Author information

1
Octavio Rodriguez-Gomez, MD., Gran Via De Carles III, 85 BIS. CP: 08028. Barcelona. Spain, E-mail: orodriguez@fundacioace.com, Fax: 0034 934193542, Telephone number: 0034 934304720.

Abstract

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.

KEYWORDS:

Subjective cognitive decline ; biomarkers; longitudinal study; preclinical AD

PMID:
29186280
DOI:
10.14283/jpad.2016.122
[Indexed for MEDLINE]

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