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NCT01315639: BALTAZAR
New Biomarker for Alzheimer's Disease Diagnostic
NA trial testing biomarkers, MRI and CSF in Alzheimer's Disease in 1,067 participants. Completed in 16 March 2018.
26 February 2015
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 1,067 |
| Start date | 3 September 2010 |
| Primary completion | 26 February 2015 |
| Estimated completion | 16 March 2018 |
| Sites | 1 location across France |
Drugs / interventions tested
- biomarkers, MRI and CSF — full drug profile →
Conditions studied
- Alzheimer's Disease — all drugs for Alzheimer's Disease →
- Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
45 and older, any sex, with Alzheimer's Disease or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to examine the relationship between plasma putative biomarkers for Alzheimer's disease (i.e. Ab40 amyloid and total Ab42 amyloid, free, bound, free/bound, truncated, sAPPα) and : * the risk of conversion of individuals with Mild Cognitive Impairment (MCI) into Alzheimer's disease (AD), * the Alzheimer's disease progression rate.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Plasma phosphorylated tau 181 predicts amyloid status and conversion to dementia stage dependent on renal function.
Lehmann S, Schraen-Maschke S, Vidal JS, Delaby C, et al · · 2023 · cited 56× · PMID 37012068 · DOI 10.1136/jnnp-2022-330540 -
Clinical value of plasma ALZpath pTau217 immunoassay for assessing mild cognitive impairment.
Lehmann S, Schraen-Maschke S, Vidal JS, Delaby C, et al · · 2024 · cited 43× · PMID 38658136 · DOI 10.1136/jnnp-2024-333467 -
Clarifying the association of CSF Aβ, tau, BACE1, and neurogranin with AT(N) stages in Alzheimer disease.
Lehmann S, Schraen-Maschke S, Buée L, Vidal JS, et al · · 2024 · cited 16× · PMID 39380095 · DOI 10.1186/s13024-024-00755-3 -
Blood Neurofilament Levels Predict Cognitive Decline across the Alzheimer's Disease Continuum.
Lehmann S, Schraen-Maschke S, Vidal JS, Blanc F, et al · · 2023 · cited 14× · PMID 38139190 · DOI 10.3390/ijms242417361 -
Head-to-Head Comparison of Two Plasma Phospho-tau Assays in Predicting Conversion of Mild Cognitive Impairment to Dementia.
Lehmann S, Schraen-Maschke S, Vidal JS, Delaby C, et al · · 2023 · cited 9× · PMID 37654065 · DOI 10.1093/clinchem/hvad103 -
Somatostatin and Neuropeptide Y in Cerebrospinal Fluid: Correlations With Amyloid Peptides Aβ<sub>1-42</sub> and Tau Proteins in Elderly Patients With Mild Cognitive Impairment.
Duron E, Vidal JS, Grousselle D, Gabelle A, et al · · 2018 · cited 7× · PMID 30327597 · DOI 10.3389/fnagi.2018.00297 -
Association of caffeine consumption with cerebrospinal fluid biomarkers in mild cognitive impairment and Alzheimer's disease: A BALTAZAR cohort study.
Blum D, Cailliau E, Béhal H, Vidal JS, et al · · 2024 · cited 5× · PMID 39099181 · DOI 10.1002/alz.14169 -
Beyond amyloid and tau: synaptic and neurodegenerative biomarkers shape MCI progression
Delaby C, Schraen-Maschke S, Paquet C, Blanc F, et al · · 2025 · DOI 10.1101/2025.10.06.25337445
Verify or expand the search:
- PubMed search for NCT01315639
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01315639 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 12 September 2025
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/NCT01315639.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing