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Active, not recruiting Not applicable

New Imaging Biomarkers Predictive of MA Progression

NCT05939362 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-10-02
Last updated
2026-10-13

Condition(s) studied

Alzheimer DiseaseMagnetic Resonance SpectroscopyUltra High Field 7TProgression of DiseaseMR Biomarkers

Investigational drug(s) / intervention(s)

MRI follow-up

MRI follow-up: MRI follow-up for patient with early onset Alzheimer's disease

Study summary

The pathophysiology of AD is complex. In addition to amyloid plaques and neurofibrillary degeneration, there is a metabolic alteration of the energy pathways, oxidative phosphorylation and glycolysis, which are involved in brain function. Several authors have shown a series of early metabolic dysregulations via an increase in phosphorylation at the origin of neuronal death.

Ultra-high field imaging (7T MRI) may allow, with its better spatial resolution and advanced imaging techniques, to shed light on the mechanisms of progression of Alzheimer's disease. A Magnetic Resonance Spectroscopy (MRS) examination can be coupled to brain MRI without additional risk for the patient. Multinuclear 1H-31P metabolic imaging is a promising tool that can provide information on the metabolic evolutionary profile of AD. Thus, we propose a longitudinal study in patients with early-stage AD on 7T MRI-MRS.

Eligibility

Sex
ALL
Min age
60 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * French-speaking patients aged 60 to 90 years, * Patient in the context of Alzheimer's disease \* for which imaging after MRI is prescribed as part of the usual diagnostic process, \*Alzheimer's disease is diagnosed by the doctor of the memory consultation and is defined by :Evidence of a storage disorder in verbal episodic memory at LR/RI defined by a sum of LR \< 17/48 and sum of RT \< 40/48 +/- Impairment of executive functions possible (BREF, TMT grefex, verbal fluencies) +/- Impairment of instrumental functions possible (Grémots noun naming, Rey's figure, Mahieux's Battery). * MMSE score ≥18, * Written informed consent after the patient has been informed, * Progressive decline for at least 6 months. Exclusion Criteria: --Partially or completely illiterate patient unable to read and write, * Patient with an absolute contraindication to 7T MRI * Severe psychiatric pathology not balanced, * Non-degenerative neurological disease (stroke, multiple sclerosis ...), * Patient with tumor or inflammatory pathology, or vascular leukopathy visualized in MRI (Fazekas score \> 3)

Primary outcome measure(s)

  • To identify Magnetic Resonance Imaging biomarkers concentration (mmol/l) at baseline that are predictive of disability progression in individuals with Mild Alzheimer's disease as assessed by the Clinical Dementia Rating (CDR) scale — Baseline
    CDR scale : No dementia (CDR = 0), Uncertain disorders (CDR = 0.5), Mild disorders (CDR = 1), Moderate disorders (CDR = 2), Severe disorders (CDR = 3).

Trial sites (1)

FacilityCityRegionStatus
Chu Poitiers Poitiers France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05939362 on ClinicalTrials.gov ↗ ← All trials in France