Clinical trial NCT03863041: Study of Phosphorylated Metabolism Profile as Predictive Biomarker of Cognitive Decline in Memory Complaint.
Official title: Study of Phosphorylated Metabolism Profile as Predictive Biomarker of Cognitive Decline in Memory Complaint.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Memory Complaint
Alzheimer Disease
Phosphorylated Metabolism Profile
Magnetic Resonance Spectroscopy
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 49
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: phosphorylated metabolism profile assessment as predictor of cognitive decline in patients with memory complaint.
timeFrame: ONE YEAR
Secondary outcomes:
measure: Correlation between phosphorylated metabolite and final diagnostic of Alzheimer disease or not.
timeFrame: ONE YEAR
measure: Correlation between phosphoryled metabolite and variability of cerebro spinal fluid biomarkers
timeFrame: ONE YEAR
measure: Correlation between multinuclear magnetic resonance spectroscopy data and severity of cognitive dysfunction, at the inclusion and at one year.
timeFrame: ONE YEAR
measure: Evolution of multinuclear magnetic resonance spectroscopy data at one year and cognitive decline at one year.
timeFrame: ONE YEAR
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU of Poitiers
Study officials:
References: