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Biobank and Brain Health in Bordeaux. (B-cube)

U

University Hospital of Bordeaux

Status

Enrolling

Conditions

Aging
Mental Processes
Behavioral Symptoms
Cognition
Immunosenescence
Anxiety
Neurocognitive Disorders
Mental Health
Alzheimer Disease
Mental Disorders
Cognitive Aging
Depression
Dementia
Brain Diseases
Brain

Treatments

Other: Neuroimaging
Other: Saliva collection and nasal or nasopharyngeal swab
Other: Hair and a tonenail (or hand nail) sampling
Other: Questionnaires
Other: Fasting blood sampling.
Other: Medical visit
Other: Urine samples
Other: Measurements
Other: Nasal microbiota

Study type

Observational

Funder types

Other

Identifiers

NCT05322343
CHUBX 2020/34

Details and patient eligibility

About

B cube is a new generation cohort to study the determinants and natural history of brain aging, using molecular epidemiology, in a representative sample (N=2000) of the general population from the age of 55 (the approximate age of onset of the first cognitive disorders and a target population particularly receptive to prevention messages). Special interest will be given to nutrition, a promising environmental exposure for prevention.

Full description

Cognitive aging and associated pathologies, primarily dementia and its main cause Alzheimer's disease, are a major public health issue. Because of the under-diagnosis of dementia in the population and the very long preclinical phase of these diseases, population-based cohorts are essential to better understand brain aging. With the PAQUID and 3-Cités cohorts, the Bordeaux Population Health Research Center (BPH) has been a world pioneer in population-based studies on aging and dementia, and has thus contributed greatly to a better understanding of age-realted brain diseases. As these cohorts are aging, and in view of the importance of studying the early stages of brain aging, it seems essential to continue our research efforts for the prevention of cognitive aging with the establishment of a new cohort of young seniors. In addition to the population-based design of the study, the representativeness of the cohort appears to be a crucial issue (since population-based cohorts depend on the voluntary participation of healthy individuals, unfavorable exposures and altered health states are often largely under-represented, which reduces the variability of exposures and events, leading to an underestimation of prevalences, a decrease in statistical power and a potential bias in the estimation of associations). Finally, the multifactorial nature of brain ageing pathologies now calls for the replacement of the reductionist approach of risk factors by a more holistic vision of the exposome (defined as all the environmental exposures with which an individual is confronted throughout the lifecourse). The development of an integrated approach of complex, high-dimensional, multi-omics biological data (genomics, transcriptomics, epigenomics, metabolomics, proteomics), applied to various biological matrices, is an indispensable tool to deep phenotyping and to the establishment of a new generation etiological epidemiological research framework in the field of brain aging pathologies.

The Biobank and Brain health in Bordeaux cohort (B cube) will include the completion of a general questionnaire (during the V1 visit), a dietary survey (during the V1, V4 and V5 visits), a computerized cognitive battery (during the V1 visit), a collection of biological material (blood, urine, stool, saliva, hair, nails and nasopharyngeal swab) for the constitution of a biobank (during the V2 biobank visit, 2000 samples of blood, urine, hair, nails and 1000 samples expected for the other fluids/samples) An MRI will be performed in volunteers aged 55 to 70 years (during the V3 visit). Finally, a complementary visit by a medical specialist may be proposed to participants with cognitive disorders or Parkinson's syndrome.

Enrollment

2,000 estimated patients

Sex

All

Ages

55 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

For the main study:

  1. live in Bordeaux metropolitan area,
  2. be between 55 and 80 years old (included),
  3. selected in terms of socioeconomic level, according to a sampling strategy by age groups and income categories representative of the general population between 55 and 80 years of age
  4. be affiliated with the social security system,
  5. agree to take a blood sample for the biobank.

For the MRI sub-study: be between 55 and 70 years old (included). Inclusion criteria for the immune response substudy: be 70 years of age or older or participate in the MRI study; agree to take a supplemental blood sample for this substudy.

Exclusion criteria

For the main study: persons under guardianship (or more generally under protection), unable to give consent to participate.

For the MRI sub-study: have a contraindication to MRI examination (pacemaker, a valve prosthesis or any other internal electrical/magnetic device; history of neurosurgery or aneurysm; claustrophobia; presence of metal fragments in the eyes, brain or spinal cord).

Trial design

2,000 participants in 1 patient group

Prospective cohort
Description:
The general population from the age of 55.
Treatment:
Other: Nasal microbiota
Other: Measurements
Other: Urine samples
Other: Medical visit
Other: Fasting blood sampling.
Other: Hair and a tonenail (or hand nail) sampling
Other: Questionnaires
Other: Neuroimaging
Other: Saliva collection and nasal or nasopharyngeal swab

Trial contacts and locations

1

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Central trial contact

Cécilia SAMIERI, Dr

Data sourced from clinicaltrials.gov

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