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New Imaging Biomarkers Predictive of MA Progression (MR7T-PRADA)

Primary Purpose

Alzheimer Disease, Magnetic Resonance Spectroscopy, Ultra High Field 7T

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI follow-up
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alzheimer Disease

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Chu PoitiersRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patient with early onset Alzheimer's disease

Arm Description

Outcomes

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
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).
Correlation between Imaging biomarkers concentration (mmol/l) and Urinary metabolic parameters (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12).
Correlation between Imaging biomarkers concentration (mmol/l) and Enzymatic and protein parameters concentration (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12).
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)
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

Full Information

First Posted
March 1, 2023
Last Updated
October 10, 2023
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05939362
Brief Title
New Imaging Biomarkers Predictive of MA Progression
Acronym
MR7T-PRADA
Official Title
Identifying Imaging Biomarkers Predictive of Disability Progression in Alzheimer's Disease: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
October 2, 2026 (Anticipated)
Study Completion Date
January 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Magnetic Resonance Spectroscopy, Ultra High Field 7T, Progression of Disease, MR Biomarkers

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patient with early onset Alzheimer's disease
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
MRI follow-up
Intervention Description
MRI follow-up for patient with early onset Alzheimer's disease
Primary Outcome Measure Information:
Title
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
Description
CDR scale : No dementia (CDR = 0), Uncertain disorders (CDR = 0.5), Mild disorders (CDR = 1), Moderate disorders (CDR = 2), Severe disorders (CDR = 3).
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Correlation between Imaging biomarkers concentration (mmol/l) and plasma metabolic parameters concentration (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12).
Time Frame
up of 12 months
Title
Correlation between Imaging biomarkers concentration (mmol/l) and Urinary metabolic parameters (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12).
Time Frame
up of 12 months
Title
Correlation between Imaging biomarkers concentration (mmol/l) and Enzymatic and protein parameters concentration (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12).
Time Frame
up of 12 months
Title
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)
Time Frame
up of 12 months
Title
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
Time Frame
up of 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adrien JULIAN, Dr
Phone
05.49.44.44.44
Ext
+33
Email
adrien.julian@chu-poitiers.fr
Facility Information:
Facility Name
Chu Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrien Julian

12. IPD Sharing Statement

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New Imaging Biomarkers Predictive of MA Progression

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