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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03863041
• Other study ID #: IRMAPHO
• Status: Completed
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: June 15, 2023

Study information

• Verified date: October 2023
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Magnetic Resonance Spectroscopy
• Memory Complaint
• Phosphorylated Metabolism Profile

Intervention

Other:
• Additional sequence performed during MRI scan
An additional sequence will be performed during the MRI scan.

Locations

Country	Name	City	State
France	CHU of Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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