FACEHBI - Fundació ACE Healthy Brain Initiative
Subjective memory complaints and their meaning
- The aim of this clinical trial is to test whether subjective memory complaints are a reliable marker for developing dementia or Alzheimer's disease.
- Fundació ACE will monitor 200 people without cognitive impairment.
FACEHBI (Fundació ACE Healthy Brain Initiative) is a study that began in December 2014. It aims to study the subjective memory complaints of 200 people without cognitive impairment, but who notice that they have memory leaks. Over time, it has been seen that acting in the early stages where Alzheimer's is not yet present Mild Cognitive Impairment could be key to developing drugs that allow Alzheimer's to act later.
The participants in this study are all over 50 years old and are healthy people who present subjective memory complaints. However, they should be people who do not have major depression or anxiety as they are factors that interfere directly in a correct functioning of memory. These people are followed up for two years. However, FACEHBI is an observational study.
This study, officially cataloged as a clinical trial, is approved by the Spanish Medicines Agency and the Ethical Committee of the Hospital Clínico de Barcelona.
The study consists of three main phases:
1) When they enter they are given a complete battery of tests. 2) After one year a follow-up medical visit is made. 3) When the two years are over, the same battery of tests that were made at the beginning is repeated.
Likewise, the tests that are carried out are the following:
- Memory tests: they are usually deeper and more exhaustive than those that are done in a conventional visit. - Blood analytics: Protein levels are detected and calculated (betamiloid, in this case) and also carries out genetic analysis, besides the determinations of a conventional analytic (glucose, thyroid, etc.) to rule out other physical diseases. - Magnetic resonance: it is a neuroimaging test that includes the most advanced sequences, that is, the brain structure is checked and its evolution is studied in the time that the study lasts. - Tests of personality and habits of life. - Amyloid PET: Amyloid PET is a neuroimaging test that detects the accumulation of amyloid protein in the brain.
The main objectives of the study are:
- To study whether subjective memory complaints, although they can not be objectified in any error, are a marker of risk and / or make these people more at risk of developing dementia or Alzheimer's. This will be discovered with patient follow-up for two years, although Fundación ACE does not rule out extending it any longer in the future.
- Identify biomarkers (parameters that can be measured, for example in blood or MRI) that can identify the risk of developing dementia or Alzheimer's. This is possible thanks to time tracking by comparing the results of different tests between people who have developed Alzheimer's and those who do not. This study will also allow us to observe alterations that may manifest in very early stages, when there is still no slight cognitive impairment but subjective memory complaints.