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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Magnetic Resonance Spectroscopy; Memory Complaint; Phosphorylated Metabolism Profile
• Intervention / Treatment: Other: Additional sequence performed during MRI scan

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France
    • CHU of POITIERS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Additional MRI SCAN sequence; Additional sequence performed during MRI scan	Other: Additional sequence performed during MRI scan; An additional sequence will be performed during the MRI scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	ONE YEAR

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	ONE YEAR
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)	ONE YEAR
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.	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.	ONE YEAR

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: IRMAPHO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No