Biobank and Brain Health in Bordeaux.

Depression Clinical Trial

— B-cube  

Official title:

Biobank and Brain Health in Bordeaux. A Population-based Cohort to Study the Biology of Brain and Cognitive Aging in Young Seniors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05322343
• Other study ID #: CHUBX 2020/34
• Status: Recruiting
• Start date: March 22, 2022
• Est. completion date: September 21, 2025

Study information

• Verified date: October 2023
• Source: University Hospital, Bordeaux
• Contact: Cécilia SAMIERI, Dr
• Phone: 5 57 57 45 15
• Email: cecilia.samieri[@]u-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: September 21, 2025
• Est. primary completion date: September 21, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Other:
• Questionnaires
Participants will complete a series of three questionnaires at the V1 visit (at home, by a trained interviewer): A general questionnaire, with collection of general health history and exposure data A nutritional survey (24-hour recall), that will be repeated by telephone twice at 3-month intervals, at the V4 and V5 visits. 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.
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.
• Saliva collection and nasal or nasopharyngeal swab
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 samples
During the V2 visit, the nurse will collect urine samples collected by the participant in the week preceding the appointment, using the equipment provided and kept in the refrigerator.
• Hair and a tonenail (or hand nail) sampling
During the V2 visit, the nurse will collect some hair and a toenail sample from the participant, in a dedicated envelope
• Nasal microbiota
Nasal or nasopharyngeal swab
• Measurements
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. 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
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
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.

Locations

Country	Name	City	State
France	University Hospital of Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Biobank inventory	of the following biological samples	Week 1
Secondary	Cognitive performance, assessed through: non-verbal cognition-Neuropsychological	Cambridge Neuropsychological Test Automated Battery (CANTAB)	Inclusion visit
Secondary	Cognitive performance, assessed through: non-verbal cognition - Verbal fluency	Isaacs' set test (IST)	Inclusion visit
Secondary	Cognitive performance, assessed through: non-verbal cognition -Dementia	Clinical Dementia Rating scale-Sum of Boxes (CDR-SOB)	Inclusion visit
Secondary	Cognitive performance, assessed through: non-verbal cognition- Mental	Mini Mental State Examination (MMSE)	Inclusion visit
Secondary	Assement anxiety and depressive symptomatology - Anxiety	Spielberger State-Trait Anxiety Inventory (STAI)	Inclusion visit
Secondary	Assement anxiety and depressive symptomatology - Drepression	Center for Epidemiological Studies-Drepression scale (CES-D).	Inclusion visit
Secondary	Nutrition and Lifestyle evaluated	Eating habits :The average of 3 recalls of 24 hours at 3-month intervals	week 12 and week 24
Secondary	Study to the microbiota intestinal, nasal and salivary	Heterogeneity and diversity.	Week 1
Secondary	Immunosenescence mechanism study	Identification of mechanisms immunosenescence	Week 1
Secondary	Cognitive performance, assessed through: non-verbal cognition- Mental	episodic memory: Free and Cued Selective Reminding test (FCSRT) (Grober & Buschke test in French)	inclusion visit
Secondary	Cognitive performance, assessed through: non-verbal cognition- Mental	Executive functions: Trail Making tests A and B (TMTA and B)	inclusion visit
Secondary	Incapacity and dependance	Estriction to mobility (Rosow and Breslow)	inclusion visit
Secondary	Incapacity and dependance	Instrumental and basic activities of Daily Living (Lawton, Katz)	inclusion visit
Secondary	Incapacity and dependance	Degree of dependency according to french health insurance system (AG.G.I.R)	inclusion visit
Secondary	Nutrition and Lifestyle evaluated	Physical activity (International Physical Activity Questionnaire)	week 12 and week 24
Secondary	Nutrition and Lifestyle evaluated	other lifestyle factors (smoking and alcohol intakes)	week 12 and week 24