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New Imaging Biomarkers Predictive of MA Progression (MR7T-PRADA)

P

Poitiers University Hospital

Status

Enrolling

Conditions

Alzheimer Disease
MR Biomarkers
Progression of Disease
Ultra High Field 7T
Magnetic Resonance Spectroscopy

Treatments

Other: MRI follow-up

Study type

Interventional

Funder types

Other

Identifiers

NCT05939362
MR7T-PRADA

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

60 to 90 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

patient with early onset Alzheimer's disease
Experimental group
Treatment:
Other: MRI follow-up

Trial contacts and locations

1

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Central trial contact

Adrien JULIAN, Dr

Data sourced from clinicaltrials.gov

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