NCT07100470 · NOT YET RECRUITING

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

This study uses two specialized brain scans — a sodium MRI (which measures salt concentrations in brain cells) and an FDG-PET scan (which measures glucose metabolism) — to see whether they can better distinguish Alzheimer's disease from frontotemporal dementia earlier and more accurately. It is a diagnostic study, not a treatment trial, meaning no drug or therapy is being tested. The goal is sharper, earlier identification of which disease a person actually has.

Eligibility criteria

Inclusion Criteria:
* 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)
  * 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.
Exclusion Criteria:
* 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

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-08-03

View full record on ClinicalTrials.gov

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