New Imaging Biomarkers Predictive of MA Progression

NCT ID: NCT05939362

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2028-01-15

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patient with early onset Alzheimer's disease

Group Type EXPERIMENTAL

MRI follow-up

Intervention Type OTHER

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

Interventions

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MRI follow-up

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Poitiers

Poitiers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Adrien JULIAN, Dr

Role: CONTACT

Phone: 05.49.44.44.44

Email: [email protected]

Facility Contacts

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Adrien Julian

Role: primary

Other Identifiers

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MR7T-PRADA

Identifier Type: -

Identifier Source: org_study_id