New Imaging Biomarkers Predictive of MA Progression

NCT05939362 | Recruiting

• 1 other identifier: MR7T-PRADA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

patient with early onset Alzheimer's disease

EXPERIMENTAL

Other: MRI follow-up

Interventions

MRI follow-up OTHER

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

patient with early onset Alzheimer's disease

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Chu Poitiers

Poitiers, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Adrien JULIAN, Dr

CONTACT

05.49.44.44.44; adrien.julian@chu-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: July 11, 2023
• Study Start: October 2, 2023
• Primary Completion (Estimated): October 2, 2027
• Study Completion (Estimated): January 15, 2028
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)