NCT06825663

Brief Summary

Basic research data from the literature on the links between cerebral insulin resistance and Alzheimer's disease (AD) suggest that this pathophysiological mechanism is involved at a very early stage in the development of the disease. The insulin receptor (IR) is a tyrosine kinase receptor whose activation by insulin binding leads to autophosphorylation of its IRβ subunits and then of the insulin receptor substrate proteins (IRS-1). The ratio of IRS residues phosphorylated on serine 312 (P(Ser312)-IRS-1) to total phosphorylated IRS or IRS phosphorylated on its tyrosines has been proposed by some authors as an index of insulin resistance in the brain. IRS-1 proteins can be measured in exosomes, and in particular in neuronal exosomes isolated from plasma. It is therefore conceivable to measure this index in these biological samples specifically derived from neurons and available from a simple blood test, in order to determine whether it could be of prognostic interest in patients with mild cognitive impairment (MCI), in particular by making it possible to identify at an early stage patients who are going to convert to AD.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
28mo left

Started Mar 2025

Longer than P75 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Mar 2025Sep 2028

First Submitted

Initial submission to the registry

February 10, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

February 13, 2025

Status Verified

May 1, 2024

Enrollment Period

2.5 years

First QC Date

February 10, 2025

Last Update Submit

February 10, 2025

Conditions

Prognosis Biomarker of ADMild Cognitive ImpairmentBrain Insuline Resistance

Keywords

Alzheimer' diseasebiomarkerBlood neuronal exosomesBrain insuline resistance

Outcome Measures

Primary Outcomes (1)

  • prognostic performance of insulin resistance indexes

    Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of Pser312-IRS1/Ptyr-IRS1 and Pser312-IRS1/IRS1 ratios measured at t0 (inclusion visit) Threshold value for these ratios to predict conversion to AD to be defined (no thresholds for these ratios in the literature) Conversion to AD defined by the clinician according to usual practice

    3 years

Secondary Outcomes (4)

  • prognostic performance of insulin resistance indexes in diabetic and non-diabetic MCI patients

    3 years

  • Link between cerebral insulin resistance index and conversion time

    3 years

  • Link between cerebral insulin resistance index and glycated haemoglobin level

    3 years

  • Link between cerebral insulin resistance index and vascular resistance

    3 years

Study Arms (1)

MCI

EXPERIMENTAL

Men or women aged 18 to 75 followed for mild cognitive disorders at the Nancy CHRU CMRR for 1 to 2 years

Biological: Blood punction

Interventions

Blood punctionBIOLOGICAL

At each annual visit (+/- 3 months), 4X10 mL blood will be taken (1 dry tube, 1 heparinised tube, 2 EDTA tubes)

MCI

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women aged 18 to 75
  • Have been treated for mild cognitive impairment at the Nancy CHRU CMRR for 1 to 2 years
  • Person affiliated to a social security scheme or beneficiary of such a scheme
  • Person who has received full information on the organisation of the research and has signed an informed consent form

You may not qualify if:

  • Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
  • An adult unable to give consent
  • Person deprived of liberty by a judicial or administrative decision
  • Persons under psychiatric care by virtue of articles L. 3212-1 and L. 3213-1.
  • Pregnant women, women in labour or breastfeeding mothers
  • Persons staying in a health or social establishment for purposes other than research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Central Study Contacts

Catherine Malaplate, PhD,PharmD

CONTACT

00 33 (0)3 83 15 55 13c.malaplate@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 13, 2025

Study Start

March 15, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Last Updated

February 13, 2025

Record last verified: 2024-05