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Recruiting NCT05939362

New Imaging Biomarkers Predictive of MA Progression

No phase Interventional Alzheimer Disease Magnetic Resonance Spectroscopy Ultra High Field 7T Progression of Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI follow-up.
Who it may be relevant to
Registry conditions: Alzheimer Disease, Magnetic Resonance Spectroscopy, Ultra High Field 7T, Progression of Disease. Basic parameters: 60 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Identifying Imaging Biomarkers Predictive of Disability Progression in Alzheimer's Disease: Pilot Study

Overview

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.

Interventions

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

Primary outcome measures

  • 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 [Time frame: Baseline]
Secondary outcome measures (5)
  • Correlation between Imaging biomarkers concentration (mmol/l) and plasma metabolic parameters concentration (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12). [Time frame: up of 12 months]
  • Correlation between Imaging biomarkers concentration (mmol/l) and Urinary metabolic parameters (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12). [Time frame: up of 12 months]
  • Correlation between Imaging biomarkers concentration (mmol/l) and Enzymatic and protein parameters concentration (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12). [Time frame: up of 12 months]
  • Develop realistic mathematical models that integrate multiple parameters from all generated data to predict the progression of Alzheimer's disease, as evaluated using the Clinical Dementia Rating (CDR) [Time frame: up of 12 months]
  • Build an Artificial Intelligence (AI) algorithm to predict disability progression in individuals with Mild Alzheimer's disease, as assessed by the Clinical Dementia Rating scale [Time frame: up of 12 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Chu Poitiers — Poitiers

Identifiers

NCT: NCT05939362 · MR7T-PRADA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗