Alzheimer Disease Clinical Trial
— MR7T-PRADAOfficial title:
Identifying Imaging Biomarkers Predictive of Disability Progression in Alzheimer's Disease: Pilot Study
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | January 15, 2027 |
Est. primary completion date | October 2, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 90 Years |
Eligibility | 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). - MOCA cognitive scale score =20, - 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) |
Country | Name | City | State |
---|---|---|---|
France | Chu Poitiers | Poitiers |
Lead Sponsor | Collaborator |
---|---|
Poitiers University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). |
Baseline | |
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | up of 12 months |
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