Alzheimer DiseaseBioCogBank-ADNCT06582199
Precision Medicine in Alzheimer's Disease : Integration of Resilience Metrics and Risk Factors - Validation Cohort BioCogBank-AD
A study testing Blood sample and Neuropsychological battery tests in people with Alzheimer Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
BioCogBankAD aims at building a prospective clinical practice cohort of 244 patients with biologically confirmed mild cognitive impairment due to Alzheimer's Disease (AD) or mild AD in order to validate data regarding markers of resilience toward AD pathophysiological process discovered in an upstream project called… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Blood sample and Neuropsychological battery tests
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteFrance
- Study dates
- 31 Oct 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of AD according to IWG-2 2014 criteria
- Age 50-90 year old
- Affiliated or beneficiary of a social security scheme
- MMSE ≥ 20
- Abnormal CSF Aβ42 or Aβ40/Aβ42 ratio according to local cut-offs
- Abnormal CSF phosphorylated and total Tau according to local cut-offs
- Ability to pass neuropsychological assessments
- Availability of a brain MRI with T1 volumetric sequence performed within 1 year
Who cannot join
- Other cause of dementia
- Participation in an AD therapeutic clinical trial
- Protected adults (including individual under guardianship by court order),
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Cochin
Paris, 75014
Olivier HANON, MD, PhD, +33 1 44 08 33 81, olivier.hanon@aphp.fr
About this study
Official title: Precision Medicine in Alzheimer's Disease: Integration of Resilience Metrics and Risk Factors - Validation Cohort BioCogBank-AD
BioCogBankAD aims at building a prospective clinical practice cohort of 244 patients with biologically confirmed mild cognitive impairment due to Alzheimer's Disease (AD) or mild AD in order to validate data regarding markers of resilience toward AD pathophysiological process discovered in an upstream project called AD-Resilience.
Read the detailed description
Alzheimer's disease (AD) is a leading cause for individual and caregiver burden associated with neurodegenerative diseases (NDs) in an aging population, afflicting + 35 million people worldwide, and spiraling costs. Major advances have been made during the last 20 years in the understanding of AD pathophysiological process. It is now well demonstrated that the course of the disease extend over more than 20 years with long pre and pauci-symptomatic periods.
A major need and challenge in translational research on Alzheimer's disease (AD) is to predict disease progression rate and/or time to clinical conversion, notably in the early phases of the AD process, such as mild cognitive impairment (MCI). Current markers such as Aß and tau species measured in cerebrospinal fluid (CSF) can differentiate AD from control and are currently used in daily clinical practice to assess presence of AD pathological process in patients with cognitive complaints. However, they do not account for cellular compensation and resistance mechanisms, the so-called "resilience" process.
Consequently, both prediction of AD progression in single patients and personalized adaptation of management and treatment remain highly limited. Moreover, there is an important unmet need regarding targeted prevention.
AD-Resilience is a translational research study funded by Agence Nationale pour la Recherche (ANR) and Direction Générale de l'Organisation des Soins (DGOS) that aims at identifying and validating markers of the biological processes underlying the mechanisms of brain resilience toward AD pathological process. Using blood samples, the investigators will produce the molecular-profile data that are needed to assess the resilience and brain homeostasis status of patients facing the AD process. Results will be processed using high-end machine learning (ML) to overcome the limitations associated with sub-optimal reliability and precision of dimensional data analysis.
These biomarkers will be identified using data and samples from an already available nationwide research cohort (BALTAZAR). In order to ensure validity and facilitate transfer to clinical practice, results from this preliminary study will have to be confirmed in an independent, prospective cohort of patients reflecting the full spectrum and real-life heterogeneity of AD.
For this purpose, BioCogBankAD study aims at building this validation cohort. 244 patients with MCI or early dementia due to AD will be recruited in the present study and prospectively followed during three years. Blood samples (plasma, DNA and PaxGen) will be taken from these patients in order to measure the biomarkers previously identified in the exploratory study. Clinical follow-up including including standardized neuropsychological examination and blood sampling (plasma) will be performed annually.
- Conditions
- Alzheimer Disease
- Being tested
- Blood sample, Neuropsychological battery tests
- Keywords
- Alzheimer Disease, Mild cognitive impairment, Resilience, Biomarkers, Cohort, Clinical practice
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Plasma, DNA, RNA and PBMC Sampling
Neuropsychological battery testsBehavioural
- Short term memory: Digit span (forward and backward)
- Long term memory: Free and Cued selective reminding Test
- Language and semantic Memory : Verbal Fluency (Category and Litteral), Image Naming (DO 40)
- Praxis
- Visuo Spatial abilities: Rey-Osterrieth Complex Figure Test
- Attention and executive functions: Trail Making Test (TMT) Part A and B, Frontal Assessment Battery (FAB)
- Autonomy in daily life activities : Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL), Instrumental Activities of Daily Living (IADL)
- Mood and anxiety: Hospital Anxiety and Depression Scale (HADS)
- Cognitive reserve : Cognitive Reserve Index questionnaire (CRIq)
| Study group | Role | What they receive |
|---|---|---|
| Exploratory group | Experimental | Not described Receives: Other: Blood sample; Behavioral: Neuropsychological battery tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean levels of new blood biomarkers
assess biomarkers of biological resilience toward AD pathological process
Measured: 36 months
Secondary outcomes (6)
Mini-Mental State examination (MMSE)
assess relationship between new biomarkers (biomarkers identified in the current study on the analysis of study samples Baltazar) and cognitive decline - MMSE: 0 to 30 evaluates memory, orientation in space and time, learning and immediate memory, attention and reasoning, language and ability to perform tasks.
- Score of 27 or more: no cognitive impairment
- Score between 21 and 26: slight impairment
- Score between 11 and 20: moderate impairment
- Score below 10: severe impairment
Measured: 36 months
Cognitive performance (zScore)
assess relationship between new biomarkers (biomarkers identified in the current study on the analysis of study samples Baltazar) and cognitive decline -
Measured: 36 months
Instrumental Activities of Daily Living (IADL)
assess relationship between new biomarkers and loss of autonomy (decline on IADL) - 0 dependent to 17 Assessment of autonomy in instrumental activities of daily living - The score shows the level of autonomy: a maximum score represents maximum autonomy, and the lower the score, the lower the level of autonomy.
Measured: 36 months
Hospital Anxiety and Depression Scale (HADS)
The HAD scale is a screening instrument for anxiety and depressive disorders. It comprises 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven to depression (total D), giving two scores (maximum score for each = 21).
0 = no anxiety 21= anxiety and depressive disorders max
Measured: 36 months
Cognitive Reserve Index questionnaire (CRIq)
CRI schooling min = 0 no schooling, training or internship - Max = undefined because "+1" corresponds to each year of schooling and +0.5 for any internship of more than 6 months - CRI work is the number of years of work, rounded to a scale of 5 (0-5-10-15-20) to assess the degree of intellectual effort and personal responsibility - CRI leisure from never/rarely to often/always (checkboxes) multiplied by number of years of practice.
Score CRI :
- ≤70 = low
- 70 to 84 = low average
- 85 to 114 = average From 115 to 130 = high average
- ≥ = high
Measured: 36 months
Cerebrospinal Fluid (CSF) biomarkers of AD
correlate the new blood biomarkers levels and CSF biomarkers of AD (Aβamyloid, Tau, P Tau)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start31 Oct 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France, Institut National de la Santé Et de la Recherche Médicale, France, Centre National de la Recherche Scientifique, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Emmanuel GOGNAT, MD, PhD, Study director, Assistance Publique - Hôpitaux de ParisChristian NERRI, PhD, Study chair, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582199
- Sponsor's protocol ID
- APHP210991
- Other IDs
- 2024-A00457-40
- Acronym
- BioCogBank-AD
- Status last verified
- Mar 2026
- First submitted
- 23 Jul 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine in Alzheimer's Disease: Integration of Resilience Metrics and Risk Factors - Validation Cohort BioCogBank-AD
- ClinicalTrials.gov ID
- NCT06582199
- Acronym / sponsor ID
- BioCogBank-AD / APHP210991
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease, Mild cognitive impairment, Resilience, Biomarkers, Cohort, Clinical practice
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Research Agency, France, Institut National de la Santé Et de la Recherche Médicale, France, Centre National de la Recherche Scientifique, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BioCogBankAD aims at building a prospective clinical practice cohort of 244 patients with biologically confirmed mild cognitive impairment due to Alzheimer's Disease (AD) or mild AD in order to validate data regarding markers of resilience toward AD pathophysiological process discovered in an upstream project called AD-Resilience.
Detailed description
Alzheimer's disease (AD) is a leading cause for individual and caregiver burden associated with neurodegenerative diseases (NDs) in an aging population, afflicting + 35 million people worldwide, and spiraling costs. Major advances have been made during the last 20 years in the understanding of AD pathophysiological process. It is now well demonstrated that the course of the disease extend over more than 20 years with long pre and pauci-symptomatic periods.
A major need and challenge in translational research on Alzheimer's disease (AD) is to predict disease progression rate and/or time to clinical conversion, notably in the early phases of the AD process, such as mild cognitive impairment (MCI). Current markers such as Aß and tau species measured in cerebrospinal fluid (CSF) can differentiate AD from control and are currently used in daily clinical practice to assess presence of AD pathological process in patients with cognitive complaints. However, they do not account for cellular compensation and resistance mechanisms, the so-called "resilience" process.
Consequently, both prediction of AD progression in single patients and personalized adaptation of management and treatment remain highly limited. Moreover, there is an important unmet need regarding targeted prevention.
AD-Resilience is a translational research study funded by Agence Nationale pour la Recherche (ANR) and Direction Générale de l'Organisation des Soins (DGOS) that aims at identifying and validating markers of the biological processes underlying the mechanisms of brain resilience toward AD pathological process. Using blood samples, the investigators will produce the molecular-profile data that are needed to assess the resilience and brain homeostasis status of patients facing the AD process. Results will be processed using high-end machine learning (ML) to overcome the limitations associated with sub-optimal reliability and precision of dimensional data analysis.
These biomarkers will be identified using data and samples from an already available nationwide research cohort (BALTAZAR). In order to ensure validity and facilitate transfer to clinical practice, results from this preliminary study will have to be confirmed in an independent, prospective cohort of patients reflecting the full spectrum and real-life heterogeneity of AD.
For this purpose, BioCogBankAD study aims at building this validation cohort. 244 patients with MCI or early dementia due to AD will be recruited in the present study and prospectively followed during three years. Blood samples (plasma, DNA and PaxGen) will be taken from these patients in order to measure the biomarkers previously identified in the exploratory study. Clinical follow-up including including standardized neuropsychological examination and blood sampling (plasma) will be performed annually.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exploratory group | Experimental | Other: Blood sample, Behavioral: Neuropsychological battery tests |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of AD according to IWG-2 2014 criteria
- Age 50-90 year old
- Affiliated or beneficiary of a social security scheme
- MMSE ≥ 20
- Abnormal CSF Aβ42 or Aβ40/Aβ42 ratio according to local cut-offs
Key exclusion criteria (3 listed)
- Other cause of dementia
- Participation in an AD therapeutic clinical trial
- Protected adults (including individual under guardianship by court order),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplePlasma, DNA, RNA and PBMC Sampling | Other | Exploratory group |
| Neuropsychological battery tests* Short term memory: Digit span (forward and backward) * Long term memory: Free and Cued selective reminding Test * Language and semantic Memory : Verbal Fluency (Category and Litteral), Image Naming (DO 40) * Praxis * Visuo Spatial abilities: Rey-Osterrieth Complex Figure Test * Attention and executive functions: Trail Making Test (TMT) Part A and B, Frontal Assessment Battery (FAB) * Autonomy in daily life activities : Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL), Instrumental Activities of Daily Living (IADL) * Mood and anxiety: Hospital Anxiety and Depression Scale (HADS) * Cognitive reserve : Cognitive Reserve Index questionnaire (CRIq) | Behavioural | Exploratory group |
Primary outcome
Mean levels of new blood biomarkers
Time frame: 36 months
assess biomarkers of biological resilience toward AD pathological process
6 secondary outcomes
Mini-Mental State examination (MMSE)
Time frame: 36 months
Cognitive performance (zScore)
Time frame: 36 months
Instrumental Activities of Daily Living (IADL)
Time frame: 36 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: 36 months
Cognitive Reserve Index questionnaire (CRIq)
Time frame: 36 months
Cerebrospinal Fluid (CSF) biomarkers of AD
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emmanuel GOGNAT, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
Christian NERRI, PhD study chair
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample and Neuropsychological battery tests in people with Alzheimer Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier HANON, MD, PhD (+ 1 44 08 33 81, olivier.hanon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean levels of new blood biomarkers (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.