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ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease

StatusRecruiting
PhaseNot applicable
SponsorInSightec
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 150 to 50 Primary completion date: Dec 2025 to Jan 2028 · Completion date: Dec 2025 to Jan 2030 · Site contacts updated at 1 of 10 sitesv26 Show 3 more changesShow less
    • Primary completion date: Dec 2025 to Jan 2028
    • Completion date: Dec 2025 to Jan 2030
    • Site contacts updated at 1 of 10 sites
  2. Site contacts updated at 1 of 10 sitesv25
  3. Site contacts updated at 1 of 10 sitesv24
  4. Primary and study completion dates: Dec 2024 to Dec 2025 Study sites: 9 to 10v23 Show 1 more changeShow less
    • Study sites: 9 to 10
  5. Enrollment target: 50 to 150v22
Show 20 earlier versionsHide 20 earlier versions
  1. Study sites revised (9)v21 See this version in full on ClinicalTrials.gov ↗
  2. Site contacts updated at 1 of 9 sitesv20
  3. Site contacts updated at 1 of 9 sitesv19
  4. Site contacts updated at 1 of 9 sitesv18
  5. Enrollment target: 30 to 50 Primary completion date: Dec 2023 to Dec 2024 · Study sites: 7 to 9v17 Show 2 more changesShow less
    • Primary completion date: Dec 2023 to Dec 2024
    • Study sites: 7 to 9
  6. Site details revised at 1 of 7 sitesv16
  7. Study sites: 6 to 7v15
  8. Study sites: 3 to 6v14
  9. Enrollment target: 20 to 30 Primary completion date: Dec 2020 to Dec 2023 · Study description revisedv13 Show 2 more changesShow less
    • Primary completion date: Dec 2020 to Dec 2023
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  10. Site contacts updated at 1 of 3 sitesv12
  11. Re-verified, no change to tracked fieldsv11
  12. Enrollment target: 10 to 20 Study description revisedv10 Show 1 more changeShow less
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  13. Site contacts updated at 2 of 3 sitesv9
  14. Re-verified, no change to tracked fieldsv8
  15. Study sites: 2 to 3v7
  16. Study sites: 1 to 2v6
  17. Site contact updatedv5
  18. Site contact updatedv4
  19. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Oct 2018 to Sep 28, 2018 · Eligibility criteria shortened, about 101 wordsv3 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2018 to Sep 28, 2018
    • Eligibility criteria shortened, about 101 words

    See this version in full on ClinicalTrials.gov ↗

  20. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
InSightec
42 trials monitored
See 1 trial at risk
Alzheimer's Disease
1,152 trials monitored
See 60 trials at risk
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 disrupt the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).
Trial Details
NCT Number NCT03671889
Lead Sponsor InSightec
Conditions Alzheimer Disease
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov