NCT06582199

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
16mo left

Started Oct 2024

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Oct 2024Sep 2027

First Submitted

Initial submission to the registry

July 23, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

October 31, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

July 23, 2024

Last Update Submit

March 24, 2026

Conditions

Alzheimer Disease

Keywords

Alzheimer DiseaseMild cognitive impairmentResilienceBiomarkersCohortClinical practice

Outcome Measures

Primary Outcomes (1)

  • Mean levels of new blood biomarkers

    assess biomarkers of biological resilience toward AD pathological process

    36 months

Secondary Outcomes (6)

  • Mini-Mental State examination (MMSE)

    36 months

  • Cognitive performance (zScore)

    36 months

  • Instrumental Activities of Daily Living (IADL)

    36 months

  • Hospital Anxiety and Depression Scale (HADS)

    36 months

  • Cognitive Reserve Index questionnaire (CRIq)

    36 months

  • +1 more secondary outcomes

Study Arms (1)

Exploratory group

EXPERIMENTAL
Other: Blood sampleBehavioral: Neuropsychological battery tests

Interventions

Blood sampleOTHER

Plasma, DNA, RNA and PBMC Sampling

Exploratory group
Neuropsychological battery testsBEHAVIORAL

* 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)

Exploratory group

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Other cause of dementia
  • Participation in an AD therapeutic clinical trial
  • Protected adults (including individual under guardianship by court order),

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cochin

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Emmanuel GOGNAT, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

  • Christian NERRI, PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    STUDY CHAIR

Central Study Contacts

Olivier HANON, MD, PhD

CONTACT

+ 1 44 08 33 81olivier.hanon@aphp.fr

Valérie PLENCE, MSc

CONTACT

+33 1 54 41 11 78valerie.plence@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2024

First Posted

September 3, 2024

Study Start

October 31, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)