NCT04526262

Brief Summary

The proposed study is to evaluate initial efficacy and safety of the BBB disruption with transcranial MRI-guided focused ultrasound (ExAblate 4000 type 2.0) in patients with Alzheimer's disease. This study iw designed as a prospective, single-site, single-aarm, nonrandomized study. Assessments will be made before and three months after 2 sessions of BBB disruption with radiologic, nuclear medicine imaging and neurophysiological examinations. Relative safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

8 months

First QC Date

August 19, 2020

Last Update Submit

August 23, 2020

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • Adverse events safety profile

    The type and severity of post-procedure adverse events will be assessed for overall safety. Safety of the BBBD procedure will be evaluated through patient examination and MRI assessements during the treatment and by their standard care of follow-up MRI scans and clinical visits.

    6 months

Secondary Outcomes (3)

  • Efficacy of BBB disruption : evaluated by radiologic imaging

    6 months

  • Efficacy of BBB disruption : evaluated by nuclear medicine imaging

    6 months

  • Efficacy of BBB disruption : evaluated by neurophysiological examination

    6 months

Study Arms (1)

BBB disruption

EXPERIMENTAL

All participant in this arm will undergo 2 sessions of transcranial magnetic resonance guided focused ultrasound blood brain barrier disruption every 3 months.

Device: transcranial magnetic resonance guided focused ultrasound BBB disruption

Interventions

transcranial magnetic resonance guided focused ultrasound BBB disruptionDEVICE

The ExAblate BBB disruption procedure will be performed with ExAblate 4000 type 2.0 system, and this will be performed twice every 3 months.

BBB disruption

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 50 and 85 years, inclusive.
  • Total score of 23 or less on the Korean version of Mini Mental state Exam (K-MMSE)
  • FBB (18F-Florbetaben)-PET test result positive
  • FDB (18F-Fluorodeoxyglucose)-PET test results suspected of Alzheimer disease-induced neurodegeneration
  • Mild cognitive impairment or dementia caused by Alzheimer's disease
  • A participant who has been given a drug at a stable dose for at least three months to improve symptoms of Alzheimer's disease
  • Able to communicate during the ExAblate BBB disruption procedure
  • Able and willing to give informed consent
  • Able to attend all study visits

You may not qualify if:

  • CGA-NPI (Caregiver-Administrated Neuropsychiatry Inventory) severity score of more than 2 points for any of "Delusion", "Hallucination" or "Agitation/Aggression"
  • Known sensitivity/allergy or contraindications to MRI contrast agent(Gadovist®) or the ultrasound contrast agent (Definity®)
  • Contraindications to MRI such as non-MRI compatible implanted devices.
  • Any of the following items in MRI
  • severe ischemic changes
  • active or chronic infection/inflammation
  • acute or chronic hemorrhage
  • tumor/space occupying lesion
  • meningeal enhancement
  • intracranial hypotension
  • More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp
  • Active seizure disorder or epilepsy (seizures despite medical treatment)
  • History of a bleeding disorder, coagulopathy
  • Cardiac disease or unstable hemodynamics
  • Severely impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Yonsei University College of Medici

Seoul, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Jin Woo Chang

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2020

First Posted

August 25, 2020

Study Start

April 10, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

August 25, 2020

Record last verified: 2020-08

Locations

KR(1)