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

Not Applicable

Completed

• Conditions: Alzheimer Disease; Memory Complaint; Phosphorylated Metabolism Profile; Magnetic Resonance Spectroscopy
• Interventions: Other: Additional sequence performed during MRI scan

• Registration Number: NCT03863041
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-05
• Study Start: 2019-04-08
• Primary Completion: 2023-06-15
• Study Completion: 2023-06-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Additional MRI SCAN sequence	Additional sequence performed during MRI scan	Additional sequence performed during MRI scan

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Evolution of multinuclear magnetic resonance spectroscopy data at one year and cognitive decline at one year.	ONE YEAR	Comparison at the inclusion and at one year of brain metabolite (Pcr, ATP, PME, PDE, cho, NAA, Cr, PH) and MMS score.
Correlation between phosphoryled metabolite and variability of cerebro spinal fluid biomarkers	ONE YEAR	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.	ONE YEAR	Correlation between brain metabolite (Pcr, ATP, PME, PDE, cho, NAA, Cr, PH) and MMS score at the inclusion and at one year.
Correlation between phosphorylated metabolite and final diagnostic of Alzheimer disease or not.	ONE YEAR	Correlation between brain metabolite (Pcr, ATP, PME, PDE, cho, NAA, Cr, PH) and Alzheimer disease final diagnostic.

Trial Locations

Locations (1)

CHU of Poitiers; 🇫🇷 Poitiers, France