Understanding brain resilience in Alzheimer's disease and its variants
Official title: MECHANISMS OF NEURONAL RESILIENCE IN ALZHEIMER'S DISEASE AND ITS FOCAL VARIANTS: A PET/MR STUDY
Run by Institut National de la Santé Et de la Recherche Médicale, France · NCT04150198 · Data updated 2026-11-12
This study is trying to understand how some people with Alzheimer's disease, especially those with early symptoms, can stay resilient and cope better by looking at their brain scans and thinking abilities.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 80 Years |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 2 sites (Orsay and 1 other locations) |
| Status | Recruiting |
| Started | December 8, 2021 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2029 |
| Registry record updated | August 20, 2026 |
| Trial ID | NCT04150198 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals aged 40 to 80 years with early-onset Alzheimer's disease and specific biomarkers indicating the presence of the disease.
✕Probably not a fit
Patients with Alzheimer's disease who do not meet the inclusion criteria, such as those over 80 years old or without the required biomarkers, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the mechanisms of neuronal resilience in patients with Alzheimer's disease, particularly focusing on those with early onset symptoms and posterior cortical atrophy. By utilizing advanced PET and MRI imaging techniques, the research aims to differentiate between patients with focal and diffuse brain damage, examining their cognitive profiles and brain network reorganization. The study seeks to uncover the specific neural mechanisms that contribute to resilience in these patients, which could inform future therapeutic approaches and patient selection for treatments. The findings may enhance our understanding of the pathophysiological processes underlying Alzheimer's disease.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for Alzheimer's disease, particularly for patients with atypical presentations.
How similar studies have gone: While there have been studies on Alzheimer's disease, this particular approach focusing on neuronal resilience and the use of tau-specific PET tracers is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. For all subjects: * Affiliation to a social security insurance or beneficiary * Informed consent form signed by the participant or his / her legal representative * Participants aged 40 to 80 years. 2. Selection of AD-Y group \- In vivo proof of Alzheimer's pathology: * Determination of specific proteins on the cerebrospinal fluid (CSF, a routine care procedure). The values considered pathological (AD) are Aβ1-42 peptide \<500 (μg / ml), and / or tau protein\> 450 and phosphorylated tau protein\> 60, IATI index \<1, tau / Aβ protein ratios \> 1.23 as well as phosphorylated tau protein / Aβ1-42\> 0.211. * And / or a positive PET-amyloid imaging test. * Early-onset episodic memory deficit (\<65 years), progressive onset with evidence of hippocampal amnesic syndrome at neuropsychological assessment. In memory tests, the amnesic hippocampal syndrome is defined by: a deficit of the free recall despite a reinforced encoding, an effectiveness of the indexing or an impairment of the recognition capabilities, the presence of intrusions. The presence during the tests of false memories spontaneous (intrusions) or provoked (false recognitions) is also very contributive to the definition of amnesic syndrome of the hippocampal type. 3. PCA group selection Patients with a clinical and cognitive profile suggestive of PCA, characterized by: * an in vivo proof of the Alzheimer pathology (see selection of the AD-Y group) * a specific impairment of neuro-visual abilities, in the absence of major disorders of episodic memory (hippocampal) and executive functions. Two possible variants: * occipito-temporal variant: visuo-perceptive deficit in the foreground, early onset and progressive worsening; lack of visual identification of objects, symbols, words or faces; * biparietal variant: visuospatial deficit in the foreground, early settlement and progressive worsening; Gerstmann syndrome; Balint syndrome; gestural apraxia; visual-spatial neglect. 4. Selection of the control subjects group * Normal neurological and neuropsychological examinations. * Control subjects will be matched in age to patients. Non-inclusion Criteria: 1. General non-inclusion criteria: * Medical history of torsade de pointe or risk of torsade de pointes * Patient treated with drugs known to lengthen QT (see www.crediblemeds.org) * Contraindication to radiopharmaceutical injection: For precautions of safety of use of the radiopharmaceutical, a blood sample allowing to check the renal and hepatic functions will be realized before imagery. The delay between the sampling and the neuroimaging visit is left to the investigator's discretion based on the patient's biological results. In particular, the glomerular filtration rate will be calculated from the results obtained. In the event of renal insufficiency (GFR 30mL / min / 1.73m2), hepatic insufficiency or any other biological anomaly of grade 3 or higher detected during these analyzes, the participant will not be able to carry out PET imaging. In this case, the results of the analyzes will be sent to the doctor indicated by the participant. This evaluation, which involves a determination of serum creatinine, is part of the standard routine biological assessment performed in the context of cognitive disorders Inability to provide informed consent by participant or legal representative: * Patient deprived of liberty by decision of justice or not benefiting from social cover. * Person in the process of participating in another therapeutic research or in a period of exclusion from another research. * Participants with a contraindication to MRI: pacemaker or cardiac defibrillator, implanted equipment activated by an electrical, magnetic or mechanical system, haemostatic clips of intracerebral aneurysms or carotid arteries , carriers of orthopedic implants. * Contraindication to radiopharmaceutical injection: known hypersensitivity to the active substance or to any of the excipients, renal impairment (GFR 30mL / min / 1.73m2), hepatic insufficiency or any other biological abnormality of grade 3 or higher * Person suffering from claustrophobia. * Pregnancy (for women of childbearing age, a urine pregnancy test will be performed on the day of the inclusion visit and the PET-MRI examination). * Any symptoms or biological values suggestive of a systemic disorder (renal, hepatic, cardiovascular, pulmonary) or any other medical conditions that could interfere with the interpretation of test results or compromise the health of patients. * Person subject to a legal safeguard. 2. Specific non-inclusion criteria for AD-Y and PCA patients: * Sudden appearance of cognitive deficits. * Gait disturbances, convulsions, major behavior modification. * Focal alterations to neurological examination, extrapyramidal signs, hallucinations, fluctuations. cognitive. * Psychiatric, cerebrovascular, metabolic, inflammatory pathology. 3. Specific non-inclusion criteria for control subjects: * Pathological neurological examination * History of neurological disease (in particular ischemic stroke or neurodegenerative disease) or psychiatric illness (particularly severe depression, psychosis, or bipolar illness still requiring drug treatment at the time of inclusion) * Physical affection that is serious or can interfere with cognitive functions.
Where it's running
-
Service Hospitalier Frédéric Joliot SHFJ
Orsay, France Recruiting -
Service de Médecine Nucléaire - Hopital La Pitié Salpetriere
Paris, France Recruiting
Study contacts
- Study coordinator: Marie Odile Habert, MCU-PH
- Email: marie-odile.habert@aphp.fr
- Phone: 01 57 27 40 00
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.