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New Imaging Biomarkers Predictive of MA Progression

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05939362
Acronym
MR7T-PRADA
Enrollment
80
Registered
2023-07-11
Start date
2023-10-02
Completion date
2028-01-15
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERMRI follow-up

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

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No

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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
Correlation between Imaging biomarkers concentration (mmol/l) and plasma metabolic parameters concentration (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12).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).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).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)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 scaleup of 12 months

Countries

France

Contacts

Primary ContactAdrien JULIAN, Dr
adrien.julian@chu-poitiers.fr05.49.44.44.44

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026