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NCT03739905
ExAblate Blood-Brain Barrier Opening for Treatment of Alzheimer's Disease
NA trial testing Blood Brain Barrier (BBB) Disruption in Alzheimer Disease in 35 participants. Completed in 9 April 2025.
9 April 2025
Quick facts
| Lead sponsor | InSightec |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 6 December 2018 |
| Primary completion | 9 April 2025 |
| Estimated completion | 9 April 2025 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Blood Brain Barrier (BBB) Disruption
Conditions studied
- Alzheimer Disease — all drugs for Alzheimer Disease →
Sponsor
InSightec — full company profile →
Who can join
Adults 50 to 85, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the safety and efficacy of the ExAblate® Model 4000 Type 2.0 system as a tool to open the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Alzheimer's disease drug development pipeline: 2019.
Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2019 · cited 485× · PMID 31334330 · DOI 10.1016/j.trci.2019.05.008 -
Treatment of Alzheimer's Disease and Blood-Brain Barrier Drug Delivery.
Pardridge WM. · · 2020 · cited 131× · PMID 33207605 · DOI 10.3390/ph13110394 -
Current Strategies to Enhance Delivery of Drugs across the Blood-Brain Barrier.
Teleanu RI, Preda MD, Niculescu AG, Vladâcenco O, et al · · 2022 · cited 122× · PMID 35631573 · DOI 10.3390/pharmaceutics14050987 -
MR-guided focused ultrasound liquid biopsy enriches circulating biomarkers in patients with brain tumors.
Meng Y, Pople CB, Suppiah S, Llinas M, et al · · 2021 · cited 116× · PMID 33693781 · DOI 10.1093/neuonc/noab057 -
Theranostic Strategy of Focused Ultrasound Induced Blood-Brain Barrier Opening for CNS Disease Treatment.
Chen KT, Wei KC, Liu HL. · · 2019 · cited 108× · PMID 30792657 · DOI 10.3389/fphar.2019.00086 -
Applications of focused ultrasound-mediated blood-brain barrier opening.
Gorick CM, Breza VR, Nowak KM, Cheng VWT, et al · · 2022 · cited 95× · PMID 36272635 · DOI 10.1016/j.addr.2022.114583 -
Secondary effects on brain physiology caused by focused ultrasound-mediated disruption of the blood-brain barrier.
Todd N, Angolano C, Ferran C, Devor A, et al · · 2020 · cited 94× · PMID 32470359 · DOI 10.1016/j.jconrel.2020.05.040 -
Therapeutic Agent Delivery Across the Blood-Brain Barrier Using Focused Ultrasound.
McMahon D, O'Reilly MA, Hynynen K. · · 2021 · cited 67× · PMID 33752471 · DOI 10.1146/annurev-bioeng-062117-121238
Verify or expand the search:
- PubMed search for NCT03739905
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other InSightec trials
Trials by the same sponsor.
- NCT04667715 — Safety and Effectiveness of Blood-Brain Barrier Disruption (BBBD) in Subjects With Suspected Infiltrating Glioma · NA · withdrawn
- NCT05539196 — A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advance · recruiting
- NCT05089786 — Echo-Focusing in Patients With Treatment-Resistant Neurologic and Psychiatric Indications (EF001) · NA · unknown
- NCT05565443 — MR-guided Focused Ultrasound Plus GCase · NA · recruiting
- NCT05317858 — Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03739905 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by InSightec
- Last refreshed: 21 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03739905.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing