Memory ComplaintNCT03863041
Study of Phosphorylated Metabolism Profile as Predictive Biomarker of Cognitive Decline in Memory Complaint.
A study testing Additional sequence performed during MRI scan in people with Memory Complaint and Alzheimer Disease, run by Poitiers University Hospital at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Memory Complaint, Alzheimer Disease, Phosphorylated Metabolism Profile
- What is being tested?
- Additional sequence performed during MRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2019to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Additional sequence performed during MRI scan
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional sequence performed during MRI scanOther
An additional sequence will be performed during the MRI scan.
| Study group | Role | What they receive |
|---|---|---|
| Additional MRI SCAN sequence | Other | Additional sequence performed during MRI scan Receives: Other: Additional sequence performed during MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ONE YEAR
Secondary outcomes (4)
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.
Measured: ONE YEAR
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)
Measured: ONE YEAR
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.
Measured: ONE YEAR
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.
Measured: ONE YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start8 Apr 2019
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory ComplaintStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863041
- Sponsor's protocol ID
- IRMAPHO
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2018
- Last updated
- 6 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Phosphorylated Metabolism Profile as Predictive Biomarker of Cognitive Decline in Memory Complaint.
- ClinicalTrials.gov ID
- NCT03863041
- Acronym / sponsor ID
- IRMAPHO
- Conditions
- Memory Complaint, Alzheimer Disease, Phosphorylated Metabolism Profile, Magnetic Resonance Spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Additional MRI SCAN sequence | Other | Other: Additional sequence performed during MRI scanAdditional sequence performed during MRI scan |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional sequence performed during MRI scanAn additional sequence will be performed during the MRI scan. | Other | Additional MRI SCAN sequence |
Primary outcome
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.
4 secondary outcomes
Correlation between phosphorylated metabolite and final diagnostic of Alzheimer disease or not.
Time frame: ONE YEAR
Correlation between phosphoryled metabolite and variability of cerebro spinal fluid biomarkers
Time frame: ONE YEAR
Correlation between multinuclear magnetic resonance spectroscopy data and severity of cognitive dysfunction, at the inclusion and at one year.
Time frame: ONE YEAR
Evolution of multinuclear magnetic resonance spectroscopy data at one year and cognitive decline at one year.
Time frame: ONE YEAR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: No
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Inspiring Seniors Towards Exercise Promotion to Protect Cognition
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Enrolling by invitation
The Digital Memory Notebook
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional sequence performed during MRI scan in people with Memory Complaint and Alzheimer Disease, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
phosphorylated metabolism profile assessment as predictor of cognitive decline in patients with memory complaint. (time frame: ONE YEAR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.