Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-24 @ 12:19 PM
NCT ID:
NCT03119961
Eligibility Criteria:
Inclusion Criteria:
* Age between 50 and 85 years old
* Alzheimer's disease, typical or atypical according to International Working Group-2 (IWG-2) criteria,
* diagnosed on the basis of a cognitive assessment and an MRI, showing one of the three most frequent phenotypic presentations of the disease (hippocampal amnesia or logopenic aphasia or syndrome of posterior cortical atrophy)
* certified by the CSF assay of biomarkers of the AD ratio PTau / Aβ\> 0.11.
* Mild disease (MMSE 20-26) but presently pejorative outcome: relatively young subject (\<80 years), "rapid" cognitive decline and high CSF tau rate (\> 600pg / mL, for A diagnostic threshold of Alzheimer's disease of 450pg / mL). The evaluation of the pejorative evolution will be validated by the Committee of Experts of the Memory Center (IM2A at Pitié-Salpêtrière Hospital)
* Patients under stable Alzheimer's treatment for at least 3 months prior to entry into the study and in which no change is envisaged in the next months in order to avoid a loss of chance for the patient and to consider an aggravation at cessation of treatment as an adverse event due to the opening of the BBB.
* Affiliate or beneficiary of Affiliated to the French Health care system
* Patient and caregiver (undertaking to accompany the participant to the various necessary medico-surgical visits and spending at least 3 hours per day with the patient) having signed, free and informed consent.
Exclusion Criteria:
* Allergy to Gadolinium, Xylocaine or any contraindication to contrast products used for brain imaging, or to drugs used in perioperative procedures.
* Contraindications to SonoVue®
* hypersensitivity to sulfur hexafluoride
* recent acute coronary syndrome or unstable ischemic heart disease
* heart failure, chronic or acute stage III or IV,
* patient undergoing drug therapy incorporating dobutamine,
* severe pulmonary arterial hypertension
* uncontrolled systemic hypertension,
* respiratory distress syndrome
* Severe renal impairment with glomerular filtration rate (GFR) \<30 mL / min / 1.73 m2 (Gadolinium IC)
* Hepatic impairment characterized by international normalized ratio (INR)\> 1.5 or Factor V \<50% of the standard.
* Patient taking an associated treatment considered potentially toxic to the central nervous system (CNS).
* Patient included or having participated in the 5 years preceding the inclusion in this study in another research protocol on Alzheimer's (medical treatment or medical device).
* Epilepsy or potentially pro-convulsive medication
* Ischemic or haemorrhagic stroke consisting of supracentimetric vascular leucopathy with a grade greater than 2 in the classification of Fazekas and Schmidt
* Presence of at least one lobar micro-bleeding identified in MRI performed in current care prior to inclusion (SWI sequence) in the sonication zone (left supramarginal gyrus)
* Chronic and abusive consumption of toxic (alcohol or drugs) except tobacco.
* Contra-indication to MRI (intracorporeal metallic material, claustrophobia)
* Hemostasis disorders (thrombocytopenia \<75,000, prothrombin ratio (PR) \<60%, INR\> 1.5, antiplatelet therapy or anticoagulant in progress)
* Phlebitis or active pulmonary embolism
* Patient unable to perform cognitive tests (less than 7 years of study, mother tongue different from French, severe unpaired sensory disorder).
* Patient under judicial protection
* Absence of accompanying person
* Patient with an ongoing infection clinically characterized by febrile syndrome and possible calling points (cough, pain, skin lesion, etc.) OR biologically suspected on C-reactive protein(CRP)\> 10, Procalcitonin\> 0.1, positive examination of the urine (CBEU).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT03119961
Study Brief:
Protocol Section:
NCT03119961