Alzheimer Disease Clinical Trial
Official title:
Study of Phosphorylated Metabolism Profile as Predictive Biomarker of Cognitive Decline in Memory Complaint.
NCT number | NCT03863041 |
Other study ID # | IRMAPHO |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 8, 2019 |
Est. completion date | June 15, 2023 |
Verified date | October 2023 |
Source | Poitiers University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU of Poitiers | Poitiers |
Lead Sponsor | Collaborator |
---|---|
Poitiers University Hospital |
France,
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 |
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