Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600880
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Neuronavigation-guided FUS-induced BBB Opening in Alzheimers Disease Patients and Its Effects on Brain Amyloid and Tau
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neuronavigation-guided Focused Ultrasound-induced Blood-brain Barrier Opening in Alzheimers Disease Patients and Its Effects on Brain Amyloid and Tau
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FUS-AD
Brief Summary:
The primary purpose of this phase 1b study is to further assess the safety and reversibility of focused ultrasound induced blood-brain barrier opening FUS-BBBO in participants with Alzheimers Disease AD using a single-element transducer with neuronavigation guidance Preliminary results from our phase 1a study demonstrate that our neuronavigation-guided FUS system was capable of safely and transiently open the BBB in participants with AD The information collected in this new study may be used to design future clinical trials to ultimately provide a viable alternative for treatment of AD in a safe and noninvasive manner
Our secondary objective includes the assessment of the therapeutic efficacy of FUS-BBBO in reducing amyloid beta and neurofibrillary tangles the main hallmark pathologies of AD using PET tracers Based on our preclinical studies in AD transgenic mouse models FUS-BBBO alone was able to reduce both the amyloid beta and tau protein load resulting in improvements in behavioral tasks assessing memory Therefore in this new study the effect of FUS-BBBO on the amyloid beta and tau protein load in patients with AD will be assessed through the use of PET tracers
Our secondary objective includes the assessment of the therapeutic efficacy of FUS-BBBO in reducing amyloid beta and neurofibrillary tangles the main hallmark pathologies of AD using PET tracers Based on our preclinical studies in AD transgenic mouse models FUS-BBBO alone was able to reduce both the amyloid beta and tau protein load resulting in improvements in behavioral tasks assessing memory Therefore in this new study the effect of FUS-BBBO on the amyloid beta and tau protein load in patients with AD will be assessed through the use of PET tracers
Detailed Description:
Regarding the primary purpose of this study the human module for the neuronavigator was implemented in our phase 1a trial and initial feasibility and safety in a small cohort of AD patients had been tested with a fast procedural time that required no anesthesia
Regarding the secondary objective both amyloid beta and tau protein load in the brain will be assessed at baseline before FUS-BBBO treatment and 3-weeks and 3-months after FUS-BBBO treatment to assess any short-term or long-term changes respectively
Regarding the secondary objective both amyloid beta and tau protein load in the brain will be assessed at baseline before FUS-BBBO treatment and 3-weeks and 3-months after FUS-BBBO treatment to assess any short-term or long-term changes respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None