Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03119961 : Blood Brain Barrier Opening in Alzheimer' Disease
PhasePhase 1/Phase 2
AgesMin: 50 Years Max: 85 Years
Eligibility
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 / A?> 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).
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03119961      |      Link to official Clinicaltrials.gov listing
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