BarcelonaBeta Dementia Prevention Research Clinic: a Study on Risk Factors Disclosure
Condition: Alzheimer Disease; Dementia; Mild Cognitive Impairment; Subjective Cognitive Decline
MeSH terms: Alzheimer Disease; Dementia; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Alzheimer's disease (AD) is the leading cause of dementia and its prevalence is estimated to
      exceed 100 million affects by 2050, becoming the main public health problem worldwide.
      Classically, AD has been considered a clinicopathological entity characterized by a
      progressive cognitive decline with early memory impairment followed by other cognitive
      domains, and an underlying neuropathological pattern characterized by extracellular
      accumulation of β-amyloid protein (Aβ) in the form of neuritic plaques, intracellular
      deposits of tau protein in the form of neuritic strands and neurofibrillary tangles, neuronal
      and synaptic loss and glial proliferation. In this context, a "probable" AD diagnosis was
      based on determining the presence of dementia and ruling out other potential aetiologies
      while a definite one required confirmation by post-mortem examination. In the last 15 to 25
      years, progress in imaging and cerebrospinal fluid (CSF) biomarkers has enabled a change of
      the AD conceptualization from a clinical-pathological entity to a clinical-biological one.
      These new diagnostic criteria also divides the course of AD into 3 stages: (1) a preclinical
      phase, which would include persons with positive AD biomarkers and normal cognitive
      performance (the subjective perception of cognitive decline [SCD] is also part of this
      stage); (2) a phase of mild cognitive impairment (MCI), characterized by cognitive
      performance lower than expected by age and educational level; and (3) a dementia phase, once
      cognitive deficits interfere with the activities of daily living. This new conceptualization
      brings the opportunity of identifying the disease in very early symptomatic pre-dementia
      stages or even before symptoms appear, creating a window of opportunity for dementia
      prevention.

      The lack of positive results in the different clinical trials performed to date in patients
      with AD dementia has redirected the focus of therapeutic strategies towards preventing the
      development of dementia. For this reason, a detailed characterization of risk factors is of
      vital importance for identifying the persons who could benefit from a possible preventive
      strategy, as well as the optimal moment to carry out the intervention. A recent effort by the
      Lancet Commission on Dementia Prevention, Intervention, and Care reported the relative risk
      for incident dementia of the main modifiable risk factors (low education in early life;
      hypertension, obesity, and hearing loss in midlife; smoking, depression, physical inactivity,
      social isolation, and diabetes in late life). In addition, the Framingham Heart Study has
      shown that age, marital status, BMI, stroke, diabetes, ischemic attacks, and cancer are
      independent predictors of event risk in the final multivariate model and were used to
      construct a risk algorithm. These set of risk factors associated with an increased risk of
      incident dementia can be coupled with well-known genetic risk factors such as APOE genotype
      and with the presence of very mild symptoms, like self-perception of cognitive decline to
      create individual estimates of risk for dementia, taking also into account the presence of
      cognitive decline or impairment.

      The possibility of creating individual estimates of risk of dementia implies a personalised
      medicine approach and results in a change from the traditional diagnostic paradigm to a new
      one in which people at risk are attended in order to disclose risk factor estimates and offer
      them personalised solutions. This paradigm shift brings important consequences. On one hand,
      disclosing medical information may potentially generate emotional impact, psychological
      burden or harm. Although current experience with both disclosing APOE-e4 genetic status and
      amyloid status reveals that it is safe, one still needs to understand the potential risks and
      benefits of disclosing risk estimates for developing dementia. On the other hand, newly
      designed infrastructures that are focused in the assessment and follow-up of pre-dementia
      patients at high risk to develop dementia are needed, since they clearly represent a distinct
      population from the one attending dementia clinics. These "prevention infrastructures" would
      offer individual risk profiling accompanied by personalised risk reduction plans including,
      but not limited to, primary prevention advice and secondary prevention approaches (e.g.
      inclusion in prevention clinical trials).

      With the ultimate aim of assessing and understanding the value of these "dementia prevention
      infrastructures", several research questions need to be beforehand addressed such as the
      following:

        -  Is disclosing risk factor estimates safe from the emotional and psychological point of
           view?

        -  Is there any benefits derived from the personalised plans received by subjects?

        -  Would the creation of Dementia Prevention Clinics be cost efficient? The
           BBRC-DevPrev-2018 study aims at answering the questions stated above.
    


Intervention name(s): Preventive strategies advice and dementia risk estimate disclosure
Intervention type(s): Procedure
Intervention description(s): The BBRC-DemPrev-2018 study is a multimodal lifestyle-interventional, longitudinal, and prospective study of participants with a subjective perception of cognitive decline (SCD) or with mild cognitive impairment (MCI). Participants are disclosed their 5-year dementia risk estimate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention