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NCT03030586: ADDIA

ADDIA Proof-of-Performance Clinical Study

Completed Last updated 19 September 2024
What this trial tests

trial testing volumetric MRI in Alzheimer Disease (AD) in 821 participants. Completed in 30 June 2023.

Timeline
1 September 2016
Primary endpoint
30 June 2023
30 June 2023

Quick facts

Lead sponsorAmoneta Diagnostics SAS
StatusCompleted
Study typeOBSERVATIONAL
Enrollment821
Start date1 September 2016
Primary completion30 June 2023
Estimated completion30 June 2023
Sites13 locations across France, Italy, Belgium, Switzerland, Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Amoneta Diagnostics SAS

Who can join

Adults 40 to 85, any sex, with Alzheimer Disease (AD) or Frontotemporal Lobar Degeneration. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of the ADDIA clinical Proof-of-Performance study is to validate the performance of ADDIA' blood biomarkers for diagnosis of Alzheimer's disease (AD). ADDIA clinical study is a multi-centre, non-interventional, prospective, proof-of-performance study with only one visit. About 800 well-characterized subjects will be recruited into 3 groups in 2:1:1 ratio, namely patients with Alzheimer's disease (AD), patients with non-AD neurodegenerative disease (NAD) and 200 control subjects (healthy as compared to their age). * 400 patients with Alzheimer's disease (AD): 200 patients with mild AD, 200 patients with moderate-to-severe AD, * 200 patients with non-Alzheimer's neurodegenerative diseases (NAD), * 200 controls (healthy as compared to their age).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Ocular Manifestations of Alzheimer's and Other Neurodegenerative Diseases: The Prospect of the Eye as a Tool for the Early Diagnosis of Alzheimer's Disease.
    Colligris P, Perez de Lara MJ, Colligris B, Pintor J. · · 2018 · cited 54× · PMID 30151279 · DOI 10.1155/2018/8538573
  2. A data-driven approach to optimizing clinical study eligibility criteria.
    Fang Y, Liu H, Idnay B, Ta C, et al · · 2023 · cited 6× · PMID 37141977 · DOI 10.1016/j.jbi.2023.104375
  3. Metabolomic Signatures and Machine Learning Models for Distinguishing Alzheimer's Disease and Dementia with Lewy Bodies
    Mukesha D, Sarter M, Dubray M, Durand F, et al · · 2025
  4. Metabolomic Signatures and Machine Learning Models for Distinguishing Alzheimer's Disease and Dementia with Lewy Bodies
    Mukesha D, Sarter M, Dubray M, Durand F, et al · · 2025
  5. Targeted serum metabolomic profiling and machine learning approach in Alzheimer's disease using the Alzheimer's disease diagnostics clinical study (ADDIA) cohort.
    Mukesha D, Sarter M, Dubray M, Durand F, et al · · 2025 · PMID 41004623 · DOI 10.1177/13872877251378653

Verify or expand the search:

Other recruiting trials for Alzheimer Disease (AD)

Currently open trials in the same condition.

Other Amoneta Diagnostics SAS trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03030586.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing