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

Sponsor
Poitiers University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03863041
Collaborator
(none)
49
1
1
52.8
0.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Additional sequence performed during MRI scan
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Study of Phosphorylated Metabolism Profile as Predictive Biomarker of Cognitive Decline in Memory Complaint.
Actual Study Start Date :
Apr 8, 2019
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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)

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU of Poitiers Poitiers France

Sponsors and Collaborators

  • Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT03863041
Other Study ID Numbers:
  • IRMAPHO
First Posted:
Mar 5, 2019
Last Update Posted:
Nov 29, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2021