Blood Brain Barrier Opening in Alzheimer' Disease (BOREAL1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03119961|
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : April 12, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Device: SONOCLOUD®||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/2 Open Single-arm Monocentric Study Evaluating the Tolerance and Interest of Transient Opening of the Blood-Brain Barrier by Low Intensity Pulsed Ultrasound With the SONOCLOUD® Implantable Medical Device in Mild Alzheimer's Disease Patients (MMSE 20-26)|
|Actual Study Start Date :||June 26, 2017|
|Actual Primary Completion Date :||October 2, 2020|
|Actual Study Completion Date :||October 7, 2020|
BBB opening by ultrasound
BBB opening by ultrasound
Other Name: BBB opening
- Florbetapir SUVr and Fluorodeoxyglucose MUV changes in BBB opening region of interest (ROI) [ Time Frame: Change from baseline at 4month and 8 month ]PET MRI evaluation
- Adverse events recording [ Time Frame: up to 9 months ]Clinical and MRI evaluation
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||50 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119961
|APHP - Pitié-Salpêtrière Hospital|
|Paris, France, 75651|
|Principal Investigator:||Stephane EPELBAUM, MD, PhD||Assistance Publique Hoptiaux de Paris|
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Assistance Publique - Hôpitaux de Paris|
|Other Study ID Numbers:||
2016-004145-82 ( EudraCT Number )
B2016-A01637-44 ( Other Identifier: IDRCB )
|First Posted:||April 19, 2017 Key Record Dates|
|Last Update Posted:||April 12, 2022|
|Last Verified:||November 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Amyloid Amyloid Plaque
Central Nervous System Diseases
Nervous System Diseases