New Imaging Biomarkers Predictive of MA Progression

Alzheimer Disease Clinical Trial

— MR7T-PRADA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939362
• Other study ID #: MR7T-PRADA
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Disease Progression
• Magnetic Resonance Spectroscopy

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