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FTDMetaAD_FTDNCT07100470

Metabolic Characterization of Alzheimer's Disease and Frontotemporal Dementia by 23Na-MRI and FDG-PET

A study testing Sodium MRI in people with FTD and AD, run by Centre Hospitalier St Anne.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Alzheimer's disease (AD) and frontotemporal dementia (FTD) are the most common forms of neurodegenerative dementia. However, their differential and timely diagnosis can be challenging for clinicians, therefore often closing the door for an early and possibly successful treatment before irreversible cerebral damage… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
FTD, AD, Healthy Controls
What is being tested?
Sodium MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
No sites listed yet
Study dates
1 Oct 2025to 1 Mar 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients with Alzheimer's disease
  • CDR (Clinical Dementia Rating Scale) = 0.5 or 1
  • Progressive amnestic syndrome, associated or not with other cognitive impairments
  • Biological criteria: CSF biomarkers suggestive of AD-continuum (Jack et al., 2018)
  • Patients with FTD
  • Modifications of the personality and the social conducts in the foreground (behavioral variant) (Rascovsky et al., 2011)
Show all 15Show fewer
  • Primary progressive aphasia (Gorno-Tempini et al., 2011):
  • Effortful, agrammatic speech plus at least one of: a) impaired grammar/sentence comprehension with relatively preserved single word comprehension, or b) groping, distorted speech production (apraxia of speech)
  • Semantic language disorders
  • Compatible brain imaging: profile of atrophy and/or hypometabolism on FDG-PET (or hypoperfusion on SPECT) compatible with the diagnosis of FTD and/or absence of atypia
  • Biological criteria: No AD profile on CSF biomarkers if available; if CSF not available: diagnosis based on clinical criteria left to the judgment of the investigators
  • Cognitively healthy controls
  • Absence of known psychiatric disorder
  • Score on the Folstein Mini-Mental State Examination (MMSE > or = 27) with no more than one word missing
  • Normal neuropsychological assessment for the age and the educational level, particularly Scores on the Free and Cued Selective Reminding Test (FCSRT) of >25 for free recall and >44 for total recall.

Who cannot join

  • Subject with an evolving and/or badly checked psychiatric pathology (left to the judgment of the investigator).
  • Subject with a grave, severe or unstable pathology (left to the judgment of the investigator) the nature of which can interfere with the variables of evaluation.
  • Epileptic subjects, with poor tolerance to MRI (1.5T, 3T or 7T),
  • Subject presenting contraindications to the MRI such as Pacemaker or stimulating neurosensory or implantable defibrillator, cochlear implants, eye or cerebral ferromagnetic foreign bodies close to nervous structures, metallic prostheses, neurosurgical ventriculoperitoneal shunt valves
  • Known or supposed histories (< or = 5 years) of severe alcoholism or misuse of drugs
  • Vascular, inflammatory or expansive, lesion visible on the MRI which can interfere with the criteria of diagnosis.
  • No health insurance
  • Agitation of the patient: not cooperative or agitated patients, claustrophobic subjects

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Julien Lagarde, MD, PhD contact

145656173 ext. +33

j.lagarde@ghu-paris.fr

About this study

Alzheimer's disease (AD) and frontotemporal dementia (FTD) are the most common forms of neurodegenerative dementia. However, their differential and timely diagnosis can be challenging for clinicians, therefore often closing the door for an early and possibly successful treatment before irreversible cerebral damage occurs. Hence, treatment options often become available only at a late point in time. In Alzheimer's disease, early neuroimaging markers are glucose hypometabolism and Amyloid-/Tau-depositions (PET). Recent findings from sodium magnetic resonance imaging (23Na-MRI) point to brain tissue sodium concentration as a metabolic marker of AD progression. Sodium is crucial for neurotransmission and cellular homeostasis maintained by the cellular Na+/K+-ATPase, depending on Adenosine-Triphosphate as energy source from the mitochondrial respiratory chain, also interacting with tau and amyloid. In this project, we aim to characterize disease-specific metabolic patterns in AD vs. FTD by performing 23Na-MRI in association to FDG-PET to support early positive and differential diagnosis and therapeutic follow-up in both diseases in association to clinical parameters such as CSF/blood markers and neuropsychological assessment. Assessment of 7T MRI including 23Na-MRI, 31P-MRS and 1H-MRI is planned with analysis of results in association with FDG-PET, Amyloid- and Tau-PET, blood and CSF biomarkers as well as neuropsychological and clinical assessment.

Conditions
FTD, AD, Healthy Controls
Being tested
Sodium MRI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium MRIDiagnostic test

    Sodium MRI is used to detect early metabolic alterations in neurodegenerative diseases

Study groups in NCT07100470
Study groupRoleWhat they receive
PatientsExperimentalNot described
Receives: Diagnostic Test: Sodium MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tissue sodium concentration

    Metabolic and structural analysis of brain characteristics by 23Na- MRI (tissue sodium concentration - TSC) at 7T MRI

    Measured: Within 4 months after inclusion

  2. Glucose metabolism

    FDG-PET (SUVR)

    Measured: Within 4 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2025
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion1 Oct 2028 (estimated)
  4. Study completion1 Mar 2029 (estimated)

Resources

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
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07100470
Sponsor's protocol ID
D25 A012
Acronym
MetaAD_FTD
Status last verified
Jul 2025
First submitted
28 Jul 2025
Last updated
3 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Sodium MRI in people with FTD and AD, run by Centre Hospitalier St Anne.

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 15 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julien Lagarde, MD, PhD (145656173 ext. +33, j.lagarde@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tissue sodium concentration (time frame: Within 4 months after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07100470.

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 3 Aug 2025.

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