[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|
|Phase||Phase 1/Phase 2|
|Ages||Min: 50 Years Max: 85 Years|
- Age between 50 and 85 years old
- Alzheimer's disease, typical or atypical according to International Working Group-2
- 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.
- 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
- 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
- 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
- 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
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03119961
| Link to official Clinicaltrials.gov listing