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Ultrasound
Blood-brain Barrier Opening for Alzheimer's Disease
N/A
Waitlist Available
Led By Elisa Konofagou, PhD
Research Sponsored by Elisa Konofagou
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening through 3 months post-treatment
Awards & highlights
Study Summary
This trial is testing a new technique to see if it can help deliver medication to the brain of Alzheimer's patients. The treatment uses ultrasound and participants will haveMRIs and PET scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening through 3 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening through 3 months post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total Number of Individuals with Successful Opening of the BBB
Total number of Safety Events Related to Opening of BBB
Secondary outcome measures
Change in Mini-Mental State Examination (MMSE) Score
Amyloid
Trial Design
1Treatment groups
Experimental Treatment
Group I: Focused ultrasound treatmentExperimental Treatment5 Interventions
Neuronavigation-guided focused ultrasound treatment in Alzheimer's disease patients using a single-element transducer in conjunction with Definity Microbubbles (10 μl/kg).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Definity
2007
Completed Phase 4
~520
Find a Location
Who is running the clinical trial?
Elisa KonofagouLead Sponsor
National Institute on Aging (NIA)NIH
1,669 Previous Clinical Trials
28,005,108 Total Patients Enrolled
Elisa Konofagou, PhDPrincipal Investigator - Columbia University
Columbia University
2 Previous Clinical Trials
86 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tumors or growths in your body.You have low pressure in your brain.You have had a stroke or heart problems in the past.You have ongoing gum disease, herpes, hepatitis, tuberculosis, or minor skin or respiratory infections.You have had serious asthma or significant allergic reactions to food or medicine in the past 3 years.You are 50 years old or more.You have a PET scan showing a certain type of brain plaque using a substance called Amyvid (18F-Florbetapir).You cannot have a magnetic resonance imaging (MRI) scan for medical reasons.You have had a bad reaction to MRI contrast agents or microbubbles in the past.You had surgery on your brain, including deep brain stimulation.You have metal implants in your body.Your high blood pressure is not well controlled (systolic blood pressure > 140 mmHg).You have a blood clotting disorder like hemophilia A or B.You have a history of seizures.Your kidneys are not working well, as shown by a blood test.You have had severe bleeding in your brain.You have a blood clotting problem or are taking medication to prevent blood clots.Significant shrinkage of the brain.Presence of meningeal enhancements.You currently have an infection or inflammation.You have been diagnosed with early Alzheimer's disease or mild cognitive impairment, as outlined in specific medical criteria.You scored between 12 and 26 on a test that measures memory and thinking skills.Your Modified Hachinski Ischemia Scale (MHIS) score is less than or equal to 4.Your score on the short form Geriatric Depression Scale (GDS) is less than or equal to 6.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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