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

NCT03863041 | Completed

• 1 other identifier: IRMAPHO
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Memory Complaint; Alzheimer Disease; Phosphorylated Metabolism Profile; Magnetic Resonance Spectroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlation between phosphorylated metabolite and final diagnostic of Alzheimer disease or not.

  ONE YEAR

• Correlation between phosphoryled metabolite and variability of cerebro spinal fluid biomarkers

  ONE YEAR

• Correlation between multinuclear magnetic resonance spectroscopy data and severity of cognitive dysfunction, 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.

  ONE YEAR

Study Arms (1)

Additional MRI SCAN sequence

OTHER

Additional sequence performed during MRI scan

Other: Additional sequence performed during MRI scan

Interventions

Additional sequence performed during MRI scan OTHER

An additional sequence will be performed during the MRI scan.

Additional MRI SCAN sequence

Eligibility Criteria

• Age: Up to 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU of Poitiers

Poitiers, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: March 5, 2019
• Study Start: April 8, 2019
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)