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NCT Number: NCT03863041

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.

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Key information

Conditions

Memory Complaint Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Magnetic Resonance Spectroscopy Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Phosphorylated Metabolism Profile Tauopathies

Age range

Up to 90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU of Poitiers

Poitiers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Additional sequence performed during MRI scan

Other

An additional sequence will be performed during the MRI scan.

Primary outcomes

  1. phosphorylated metabolism profile assessment as predictor of cognitive decline in patients with memory complaint.

    Time frame: ONE YEAR

    correlation between brain phosphorylated metabolism (Pcr, ATP, PME, PDE, cho, NAA, Cr, PH) at the inclusion and MMSE on 2 years.

Secondary outcomes

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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: ONE YEAR

    Comparison at the inclusion and at one year of brain metabolite (Pcr, ATP, PME, PDE, cho, NAA, Cr, PH) and MMS score.

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 5, 2019
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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