Precision Medicine in Alzheimer's Disease : Integration of Resilience Metrics and Risk Factors - Validation Cohort BioCogBank-AD
NCT Number: NCT06582199
Acronym: BioCogBank-AD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alzheimer Disease
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 244
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2027-09

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 AD-Resilience.

Primary Outcome Measures: Mean levels of new blood biomarkers, assess biomarkers of biological resilience toward AD pathological process, 36 months
Secondary Outcome Measures: 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, 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 -, 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., 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, 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, 36 months|Cerebrospinal Fluid (CSF) biomarkers of AD, correlate the new blood biomarkers levels and CSF biomarkers of AD (Aβamyloid, Tau, P Tau), 36 months