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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05939362
Other study ID # MR7T-PRADA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 2, 2023
Est. completion date January 15, 2027

Study information

Verified date October 2023
Source Poitiers University Hospital
Contact Adrien JULIAN, Dr
Phone 05.49.44.44.44
Email adrien.julian@chu-poitiers.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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)

Study Design


Intervention

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

Locations

Country Name City State
France Chu Poitiers Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

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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