Validation of Blood Biomarkers for Alzheimer's Disease

NCT05427448 | Completed

• 1 other identifier: RECHMPL21_0586
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 3

Brief Summary

Alzheimer's disease (AD) has gradually become one of the major global public health issues due to its prevalence, which increases with age and life expectancy, and the economic cost of caring for patients whose cognitive decline progressively leads to loss of functional autonomy. The diagnosis of AD is based on a multidisciplinary approach, involving, among other things, evaluation of the medical history together with clinical symptoms and signs, neuropsychological tests and neuroimaging. The quantification of cerebrospinal fluid (CSF) core biomarkers (amyloid beta peptides \[Ab1-40 and Ab1-42\], total tau \[t-tau\] and its phosphorylated form on threonine 181 \[p-tau(181)\]) has progressively proven utility for the diagnosis of AD and its prodromal forms. CSF biomarkers are now included in international guidelines for the diagnosis of AD in research settings and clinical practice and the Alzheimer's Association appropriate use criteria for the use of lumbar puncture and CSF testing in the diagnosis of AD have been published. Such biochemical diagnostics are currently implemented in many specialized centers around the world. Recent progress in the biological diagnosis of AD is considerable, with the possibility, thanks to ultra-sensitive tests realized notably with the SIMOA technology, of having Ab1-40, Ab1-42, t-tau and p-tau(181) also detectable in the blood using commercial kits. The performance for AD detection has been evaluated by many groups including on retrospective samples. It is now essential to evaluate the interest of blood-based biomarkers of AD, prospectively and in real life condition to confront them with pre-analytical and analytical variabilities. It is also important to position them in relation to CSF analysis and AD management, from risk assessment, diagnosis, to therapeutic strategies.

Conditions

Alzheimer Disease; Mild Cognitive Impairment; Dementia; Tauopathies

Keywords

blood; Alzheimer; biomarker

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of blood biomarkers for Alzheimer's disease

  Calculate the performance (sensitivity, specificity) of biomarkers, alone or in combination, for the detection of Alzheimer's disease as defined by the McKhann criteria.

  24 months

Secondary Outcomes (2)

• Prediction of CSF profile

  24 months

• Diagnostic performance of blood biomarkers for FTD or LBD

  24 months

Study Arms (1)

Prospective multisite clinical trial with consecutive recruitment.

EXPERIMENTAL

Patients consulting in memory clinics from Montpellier, Nîmes, or Perpignan. CSF AD biomarkers performed for diagnostic purpose in clinical routine practice

Diagnostic Test: Measurement of amyloid and pTau blood biomarkers

Interventions

Measurement of amyloid and pTau blood biomarkers DIAGNOSTIC_TEST

Detection of plasma Amyloid beta 1-40 and 1-42 peptide and phosphorylated tau isoforms.

Prospective multisite clinical trial with consecutive recruitment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients consulting in memory clinics from Montpellier, Nîmes, or Perpignan.
• Age \>= 18 years old
• CSF AD biomarkers performed for diagnostic purpose in clinical routine practice
• Having given their written and enlightened consent
• Affiliated or beneficiary of the national health insurance

You may not qualify if:

• Contraindication or refusal of lumbar puncture
• Patient deprived of freedom, by court or administrative order, or major protected by law
• Pregnant or breastfeeding women

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (3)

Montpellier University Hospital

Montpellier, Occitanie, 34000, France

Location

Nîmes University Hospital

Nîmes, Occitanie, 30000, France

Location

Perpignan Regional Hospital

Perpignan, Occitanie, 66000, France

Location

Related Publications (3)

• Delaby C, Alcolea D, Hirtz C, Vialaret J, Kindermans J, Morichon L, Fortea J, Belbin O, Gabelle A, Blennow K, Zetterberg H, Lleo A, Lehmann S. Blood amyloid and tau biomarkers as predictors of cerebrospinal fluid profiles. J Neural Transm (Vienna). 2022 Feb;129(2):231-237. doi: 10.1007/s00702-022-02474-9. Epub 2022 Feb 15.

  PMID: 35169889 RESULT

• Lleo A, Zetterberg H, Pegueroles J, Karikari TK, Carmona-Iragui M, Ashton NJ, Montal V, Barroeta I, Lantero-Rodriguez J, Videla L, Altuna M, Benejam B, Fernandez S, Valldeneu S, Garzon D, Bejanin A, Iulita MF, Camacho V, Medrano-Martorell S, Belbin O, Clarimon J, Lehmann S, Alcolea D, Blesa R, Blennow K, Fortea J. Phosphorylated tau181 in plasma as a potential biomarker for Alzheimer's disease in adults with Down syndrome. Nat Commun. 2021 Jul 14;12(1):4304. doi: 10.1038/s41467-021-24319-x.

  PMID: 34262030 RESULT

• Alcolea D, Delaby C, Munoz L, Torres S, Estelles T, Zhu N, Barroeta I, Carmona-Iragui M, Illan-Gala I, Santos-Santos MA, Altuna M, Sala I, Sanchez-Saudinos MB, Videla L, Valldeneu S, Subirana A, Pegueroles J, Hirtz C, Vialaret J, Lehmann S, Karikari TK, Ashton NJ, Blennow K, Zetterberg H, Belbin O, Blesa R, Clarimon J, Fortea J, Lleo A. Use of plasma biomarkers for AT(N) classification of neurodegenerative dementias. J Neurol Neurosurg Psychiatry. 2021 Nov;92(11):1206-1214. doi: 10.1136/jnnp-2021-326603. Epub 2021 Jun 8.

  PMID: 34103344 RESULT

Related Links

• Clinical proteomics

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia; Tauopathies

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Sylvain Lehmann, MD PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Prospective consecutive enrollment clinical trial to assess the diagnostic performance (sensitivity, specificity) of blood biomarkers for Alzheimer's disease.

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 22, 2022
• Study Start: November 24, 2022
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)