Biobank and Brain Health in Bordeaux.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55-80
SponsorUniversity Hospital, Bordeaux

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

None

Trial population

The general population from the age of 55.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaires

    Other intervention

    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.

  • Fasting blood sampling.

    Other intervention

    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).

  • Saliva collection and nasal or nasopharyngeal swab

    Other intervention

    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.

  • Urine and stool samples

    Other intervention

    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.

  • Hair and a tonenail (or hand nail) sampling

    Other intervention

    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.

  • Nasal microbiota

    Other intervention

    Nasal or nasopharyngeal swab

  • Measurements

    Other intervention

    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.

  • Neuroimaging

    Other intervention

    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

  • Medical visit

    Other intervention

    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.

Treatment groups

2,050 Participants
are divided into 1 treatment group
Group A: Prospective cohort9 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Inclusion visit
2

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

Time frame
week 1
3

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.

Time frame
week 2
4

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

Dietary survey

Time frame
week 12 and week 24

Secondary outcomes

1

Biobank inventory

of the following biological samples

Time frame
Week 1
2

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

Cambridge Neuropsychological Test Automated Battery (CANTAB)

Time frame
Inclusion visit and V7 (3 years after inclusion visite)
3

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

Isaacs' set test (IST)

Time frame
Inclusion visit and V7 (3 years after inclusion visite)
4

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

Clinical Dementia Rating scale-Sum of Boxes (CDR-SOB)

Time frame
Inclusion visit and V7 (3 years after inclusion visite)

Other outcomes

Sponsors and contacts

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