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Study of Phosphorylated Metabolism Profile as Predictive Biomarker of Cognitive Decline in Memory Complaint.

Primary Purpose

Memory Complaint, Alzheimer Disease, Phosphorylated Metabolism Profile

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Additional sequence performed during MRI scan
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Memory Complaint

Eligibility Criteria

undefined - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Memory complaint, leading to a medical visit at the Centre Mémoire de Ressources et de Recherche (CMRR) of Poitiers, and for which an MRI is needed in routine exploration.
  2. Age inferior at 90 years old
  3. Mini Mental State Examination (MMSE) score between 20 and 30
  4. Patient without guardianship measure, without restricted liberty.
  5. Patient who benefits from social security

Exclusion Criteria:

  1. Vascular, tumor, inflammatory pathology diagnosed by MRI
  2. Other diagnosed neurodegenerative disease than Alzheimer disease
  3. Other non neurodegenerative neurological disease
  4. Vital risk at short term
  5. Severe and uncontrolled psychiatric disease

Sites / Locations

  • CHU of Poitiers

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Additional MRI SCAN sequence

Arm Description

Additional sequence performed during MRI scan

Outcomes

Primary Outcome Measures

phosphorylated metabolism profile assessment as predictor of cognitive decline in patients with memory complaint.
correlation between brain phosphorylated metabolism (Pcr, ATP, PME, PDE, cho, NAA, Cr, PH) at the inclusion and MMSE on 2 years.

Secondary Outcome Measures

Correlation between phosphorylated metabolite and final diagnostic of Alzheimer disease or not.
Correlation between brain metabolite (Pcr, ATP, PME, PDE, cho, NAA, Cr, PH) and Alzheimer disease final diagnostic.
Correlation between phosphoryled metabolite and variability of cerebro spinal fluid biomarkers
Correlation between brain metabolite (Pcr, ATP, PME, PDE, cho, NAA, Cr, PH) and cerebro spinal fluid biomarkers (B-amyloid Tau protein and Phosphorylated-Tau Protein)
Correlation between multinuclear magnetic resonance spectroscopy data and severity of cognitive dysfunction, at the inclusion and at one year.
Correlation between brain metabolite (Pcr, ATP, PME, PDE, cho, NAA, Cr, PH) and MMS score at the inclusion and at one year.
Evolution of multinuclear magnetic resonance spectroscopy data at one year and cognitive decline at one year.
Comparison at the inclusion and at one year of brain metabolite (Pcr, ATP, PME, PDE, cho, NAA, Cr, PH) and MMS score.

Full Information

First Posted
October 24, 2018
Last Updated
October 5, 2023
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03863041
Brief Title
Study of Phosphorylated Metabolism Profile as Predictive Biomarker of Cognitive Decline in Memory Complaint.
Official Title
Study of Phosphorylated Metabolism Profile as Predictive Biomarker of Cognitive Decline in Memory Complaint.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)

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
Alzheimer disease is a frequent disease in the late ages that results in global alteration of cognitive functions. In which memory complaint can be isolated in the early stages. Physiopathology of neuronal degenerescence in Alzheimer disease is complex, two main histological lesions are known, amyloid plaques and neurofibrillar tangles. Beyond the histological knowledge, alterations of neuronal metabolism are described such as oxydative phosphorylation and glycolytic pathway. These metabolism alterations are involved in neuronal death. Multi-nucleus magnetic resonance spectroscopy is a non-invasive non-irradiant imagery technique already used in routine. This technic allows the phosphoenergetic pool assessment, that inform about cellular metabolism. The aim of the study is to explore the phosphorylated metabolism patterns as predictive biomarkers of cognitive decline in patients with a memory complaint diagnosed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Complaint, Alzheimer Disease, Phosphorylated Metabolism Profile, Magnetic Resonance Spectroscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Additional MRI SCAN sequence
Arm Type
Other
Arm Description
Additional sequence performed during MRI scan
Intervention Type
Other
Intervention Name(s)
Additional sequence performed during MRI scan
Intervention Description
An additional sequence will be performed during the MRI scan.
Primary Outcome Measure Information:
Title
phosphorylated metabolism profile assessment as predictor of cognitive decline in patients with memory complaint.
Description
correlation between brain phosphorylated metabolism (Pcr, ATP, PME, PDE, cho, NAA, Cr, PH) at the inclusion and MMSE on 2 years.
Time Frame
ONE YEAR
Secondary Outcome Measure Information:
Title
Correlation between phosphorylated metabolite and final diagnostic of Alzheimer disease or not.
Description
Correlation between brain metabolite (Pcr, ATP, PME, PDE, cho, NAA, Cr, PH) and Alzheimer disease final diagnostic.
Time Frame
ONE YEAR
Title
Correlation between phosphoryled metabolite and variability of cerebro spinal fluid biomarkers
Description
Correlation between brain metabolite (Pcr, ATP, PME, PDE, cho, NAA, Cr, PH) and cerebro spinal fluid biomarkers (B-amyloid Tau protein and Phosphorylated-Tau Protein)
Time Frame
ONE YEAR
Title
Correlation between multinuclear magnetic resonance spectroscopy data and severity of cognitive dysfunction, at the inclusion and at one year.
Description
Correlation between brain metabolite (Pcr, ATP, PME, PDE, cho, NAA, Cr, PH) and MMS score at the inclusion and at one year.
Time Frame
ONE YEAR
Title
Evolution of multinuclear magnetic resonance spectroscopy data at one year and cognitive decline at one year.
Description
Comparison at the inclusion and at one year of brain metabolite (Pcr, ATP, PME, PDE, cho, NAA, Cr, PH) and MMS score.
Time Frame
ONE YEAR

10. Eligibility

Sex
All
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Memory complaint, leading to a medical visit at the Centre Mémoire de Ressources et de Recherche (CMRR) of Poitiers, and for which an MRI is needed in routine exploration. Age inferior at 90 years old Mini Mental State Examination (MMSE) score between 20 and 30 Patient without guardianship measure, without restricted liberty. Patient who benefits from social security Exclusion Criteria: Vascular, tumor, inflammatory pathology diagnosed by MRI Other diagnosed neurodegenerative disease than Alzheimer disease Other non neurodegenerative neurological disease Vital risk at short term Severe and uncontrolled psychiatric disease
Facility Information:
Facility Name
CHU of Poitiers
City
Poitiers
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Phosphorylated Metabolism Profile as Predictive Biomarker of Cognitive Decline in Memory Complaint.

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