Clinical trial NCT05322343: Biobank and Brain Health in Bordeaux.
Official title: Biobank and Brain Health in Bordeaux. A Population-based Cohort to Study the Biology of Brain and Cognitive Aging in Young Seniors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain
Aging
Cognitive Aging
Immunosenescence
Mental Processes
Mental Disorders
Neurocognitive Disorders
Cognition
Brain Diseases
Dementia
Alzheimer Disease
Mental Health
Behavioral Symptoms
Depression
Anxiety
Keywords: Epidemiologic Methods
Risk factors
Public Health
Environmental Exposure
Exposome
Dietary Exposure
Diet
Food and Nutrition
Nutritional Status
Metabolomics
Systems biology
Environmental Biomarkers
Inflammation Mediators
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The general population from the age of 55.

Brief summary: 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.

Detailed 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.

Approximately three years after V1, a follow-up phase is proposed to the participant, comprising a block of 6 visits: a general questionnaire accompanied by a computerized cognitive battery (V7), a dietary survey (V7, V9, V10 and V11), a new collection of biological material (V8) including blood samples and hair (for all participants in the follow-up phase) and stool samples (if sampling had not taken place during V2 and for a subsample of participants at follow-up).

Eligibility criteria: 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 75 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).

Primary outcomes:
measure: Number of participants for whom samples are available in the biobank and nutritional and cognitive surveys have been completed.
timeFrame: Inclusion visit
measure: Number of participants for whom samples are available in the biobank and nutritional and cognitive surveys have been completed.
timeFrame: week 1
measure: Number of participants for whom samples are available in the biobank and nutritional and cognitive surveys have been completed.
timeFrame: week 2
measure: Number of participants for whom samples are available in the biobank and nutritional and cognitive surveys have been completed.
timeFrame: week 12 and week 24
Secondary outcomes:
measure: Biobank inventory
timeFrame: Week 1
measure: Cognitive performance, assessed through: non-verbal cognition-Neuropsychological
timeFrame: Inclusion visit and V7 (3 years after inclusion visite)
measure: Cognitive performance, assessed through: non-verbal cognition - Verbal fluency
timeFrame: Inclusion visit and V7 (3 years after inclusion visite)
measure: Cognitive performance, assessed through: non-verbal cognition -Dementia
timeFrame: Inclusion visit and V7 (3 years after inclusion visite)
measure: Cognitive performance, assessed through: non-verbal cognition- Mental
timeFrame: Inclusion visit and V7 (3 years after inclusion visite)
measure: Assement anxiety and depressive symptomatology - Anxiety
timeFrame: Inclusion visit and V7 (3 years after inclusion visite)
measure: Assement anxiety and depressive symptomatology - Drepression
timeFrame: Inclusion visit and V7 (3 years after inclusion visite)
measure: Nutrition and Lifestyle evaluated
timeFrame: week 12 and week 24
measure: Study to the microbiota intestinal, nasal and salivary
timeFrame: Week 1 and V8 (1 month after v7 (3 years after inclusion))
measure: Immunosenescence mechanism study
timeFrame: Week 1
measure: Cognitive performance, assessed through: non-verbal cognition- Mental
timeFrame: Inclusion visit and V7 (3 years after inclusion visite)
measure: Cognitive performance, assessed through: non-verbal cognition- Mental
timeFrame: Inclusion visit and V7 (3 years after inclusion visite)
measure: Incapacity and dependance
timeFrame: Inclusion visit and V7 (3 years after inclusion visite)
measure: Incapacity and dependance
timeFrame: Inclusion visit and V7 (3 years after inclusion visite)
measure: Incapacity and dependance
timeFrame: Inclusion visit and V7 (3 years after inclusion visite)
measure: Nutrition and Lifestyle evaluated
timeFrame: at the V4 (4 months after inclusion),V5 (8 mounths after inclusion) and V6 (12 months after inclusion) visits; and V7 (3 years after inclusion), V9 (4 months after v7), V10(8 months after v7) et V11(12 months after v7) for the follow-up phase
measure: Nutrition and Lifestyle evaluated
timeFrame: at the V4 (4 months after inclusion),V5 (8 mounths after inclusion) and V6 (12 months after inclusion) visits; and V7 (3 years after inclusion), V9 (4 months after v7), V10(8 months after v7) et V11(12 months after v7) for the follow-up phase
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital of Bordeaux
Study officials:
affiliation: Bordeaux Population Health Researh Center Inserm
name: Cécilia SAMIERI, Dr
role: PRINCIPAL_INVESTIGATOR
References: