New Imaging Biomarkers Predictive of MA Progression

Trial statusActive, not recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorPoitiers University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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,

MMSE score ≥18,

Written informed consent after the patient has been informed,

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • MRI follow-up

    Other intervention

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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: patient with early onset Alzheimer's diseaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

CDR scale : No dementia (CDR = 0), Uncertain disorders (CDR = 0.5), Mild disorders (CDR = 1), Moderate disorders (CDR = 2), Severe disorders (CDR = 3).

Time frame
Baseline

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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