Clinical trial NCT05939362: New Imaging Biomarkers Predictive of MA Progression
Official title: Identifying Imaging Biomarkers Predictive of Disability Progression in Alzheimer's Disease: Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Magnetic Resonance Spectroscopy
Ultra High Field 7T
Progression of Disease
MR Biomarkers
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 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)

Primary outcomes:
measure: 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
timeFrame: Baseline
Secondary outcomes:
measure: Correlation between Imaging biomarkers concentration (mmol/l) and plasma metabolic parameters concentration (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12).
timeFrame: up of 12 months
measure: Correlation between Imaging biomarkers concentration (mmol/l) and Urinary metabolic parameters (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12).
timeFrame: up of 12 months
measure: Correlation between Imaging biomarkers concentration (mmol/l) and Enzymatic and protein parameters concentration (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12).
timeFrame: up of 12 months
measure: 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)
timeFrame: up of 12 months
measure: 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
timeFrame: up of 12 months
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Chu Poitiers
Study officials:
References: