MR7T-PRADA: New Imaging Biomarkers Predictive of MA Progression

Sponsor

Poitiers University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05939362

Collaborator

(none)

Enrollment

Arm

42.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease Magnetic Resonance Spectroscopy Ultra High Field 7T Progression of Disease MR Biomarkers	Other: MRI follow-up	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jul 15, 2023

Anticipated Primary Completion Date :

Jul 15, 2026

Anticipated Study Completion Date :

Jan 15, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patient with early onset Alzheimer's disease	Other: MRI follow-up MRI follow-up for patient with early onset Alzheimer's disease

Arm

Intervention/Treatment

Experimental: patient with early onset Alzheimer's disease

Other: MRI follow-up

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

Outcome Measures

Primary Outcome Measures

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 [Baseline]
CDR scale : No dementia (CDR = 0), Uncertain disorders (CDR = 0.5), Mild disorders (CDR = 1), Moderate disorders (CDR = 2), Severe disorders (CDR = 3).

Secondary Outcome Measures

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 scale [up of 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Poitiers University Hospital

ClinicalTrials.gov Identifier:

NCT05939362

Other Study ID Numbers:

MR7T-PRADA

First Posted:

Jul 11, 2023

Last Update Posted:

Jul 11, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Disease Progression

Study Results

No Results Posted as of Jul 11, 2023