Biobank and Brain Health in Bordeaux.

NCT05322343 | Recruiting

• 1 other identifier: CHUBX 2020/34
• Study Type: observational
• Target: 2,050
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Number of participants for whom samples are available in the biobank and nutritional and cognitive surveys have been completed.

  General questionnaire and a computerized cognitive battery.

  Inclusion visit

• Number of participants for whom samples are available in the biobank and nutritional and cognitive surveys have been completed.

  Collection of biological material for the constitution of a biobank

  week 1

• Number of participants for whom samples are available in the biobank and nutritional and cognitive surveys have been completed.

  An MRI will be performed in volunteers aged 55 to 70 years.

  week 2

• Number of participants for whom samples are available in the biobank and nutritional and cognitive surveys have been completed.

  Dietary survey

  week 12 and week 24

Secondary Outcomes (17)

• Biobank inventory

  Week 1

• Cognitive performance, assessed through: non-verbal cognition-Neuropsychological

  Inclusion visit and V7 (3 years after inclusion visite)

• Cognitive performance, assessed through: non-verbal cognition - Verbal fluency

  Inclusion visit and V7 (3 years after inclusion visite)

• Cognitive performance, assessed through: non-verbal cognition -Dementia

  Inclusion visit and V7 (3 years after inclusion visite)

• Cognitive performance, assessed through: non-verbal cognition- Mental

  Inclusion visit and V7 (3 years after inclusion visite)

Study Arms (1)

Prospective cohort

The general population from the age of 55.

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

Interventions

Questionnaires OTHER

Participants will complete a series of three questionnaires at the V1 (at home, by a trained interviewer) repeated at V7 for the follow up phase: 1. A general questionnaire, with collection of general health history and exposure data 2. A nutritional survey (24-hour recall), that will be repeated by telephone twice at 3-month intervals, at the V4 and V5, V6 visits. and V7, V9, V10 et V11 for the follow-up phase 3. An evaluation of cognitive performance using a validated computerized battery (Cantab®), completed of neuropsychological tests to evaluate dementia syndromes, depressive symptoms and anxiety.

Prospective cohort

Fasting blood sampling. OTHER

In the morning, during the V2 visit by a nurse at the participant's home. Blood collection will include 8 blood tubes (volume approx.. 35.5 mL), plus 2 additional tubes for 500 participants accepting MRI, for a total volume of blood drawn of 41.5 mL for these participants. For the immunological substudy, a second sample will be taken at a distance (after 4 weeks) for 150 volunteer participants meeting the criteria. The blood collection is repeated at V8 during the follow-up phase (21 mL).

Prospective cohort

Saliva collection and nasal or nasopharyngeal swab OTHER

On the day of the V2 visit, the nurse will collect a volume of saliva that has flowed spontaneously for 5 min in a sterile 40-mL polypropylene tube, and a nasal or nasopharyngeal swab using a specific kit.

Prospective cohort

Urine and stool samples OTHER

During the V2 visit, the nurse will collect urine and stool samples collected by the participant in the week preceding the appointment, using the equipment provided and kept in the refrigerator. Stool sampling os repeated at V8 during the follow-up phase.

Prospective cohort

Hair and a tonenail (or hand nail) sampling OTHER

During the V2 visit, the nurse will collect some hair and a toenail sample from the participant, in a dedicated envelope. The hair collection is repeated at V8 during the follow-up phase.

Prospective cohort

Nasal microbiota OTHER

Nasal or nasopharyngeal swab

Prospective cohort

Measurements OTHER

In addition to the samples, anthropometric measurements (weight, height,ead, waist, hip, calf and arm circumferences, subjective evaluation of body shape trajectories over the lifecourse), blood pressure, orthostatic hypotension, walking speed, grip strength, and hearing screening of sarcopenia and Parkinson's syndromes will also be collected by the nurse on the day of the V2 visit. Some of these measures (blood pressure, grip strength, screening of sarcopenia and Parkinson's syndromes) are repeated at V8 during the follow-up visit. Analyses may be performed on the biobank samples. These analyses will include metabolite assays (Metabolon®), and may include genotyping for research purposes (without searching for specific genes.

Prospective cohort

Neuroimaging OTHER

A multi-sequence MRI will be performed at the V3 visit. None of the sequences used will require contrast injection. The MRI sequences used will be: a 3D MPRAGE T1-weighted sequence, a T2-weighted sequence (FLAIR), a diffusion EPI sequence, a magnetization transfer sequence, and a resting state functional MRI BOLD sequence. The total duration of the MRI examination will be approximately 50 minutes. The MRI will be performed at the Bioimaging Institute on an imager dedicated to research activities (3T Prisma Siemens).During V3 visit, a measurement of skin autofluorescence of advanced glycation products will also be performed

Prospective cohort

Medical visit OTHER

For the participants with cognitive disorders (evaluated by the neuropsychologist during the V1 visit) or Parkinson's syndrome (evaluated by the nurse during the V2 visit),a complementary visit by a neurologist may be proposed in order to specify the etiology of these disorders and to establish a possible diagnosis and etiology.

Prospective cohort

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The general population from the age of 55.

You may qualify if:

• For the main study:
• live in Bordeaux metropolitan area,
• be between 55 and 80 years old (included),
• 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
• be affiliated with the social security system,
• agree to take a blood sample for the biobank.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

University Hospital of Bordeaux

Bordeaux, Bordeaux, 33300, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, urine, saliva, hair, nails and nasopharyngeal swab samples

MeSH Terms

Conditions

Mental Disorders; Neurocognitive Disorders; Brain Diseases; Dementia; Alzheimer Disease; Psychological Well-Being; Behavioral Symptoms; Depression; Anxiety Disorders

Interventions

Surveys and Questionnaires; Urination; Weights and Measures; Neuroimaging

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological

Study Officials

• Cécilia SAMIERI, Dr

  Bordeaux Population Health Researh Center Inserm

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécilia SAMIERI, Dr

CONTACT

5 57 57 45 15; cecilia.samieri@u-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: April 11, 2022
• Study Start: March 22, 2022
• Primary Completion (Estimated): March 22, 2030
• Study Completion (Estimated): March 22, 2030
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)