N/A
N=6
Non-invasive Blood-brain Barrier Opening in Alzheimer's Disease Patients Using Focused Ultrasound
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT04118764 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Total Number of Individuals With Successful Opening of the BBB — 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neuronavigation-guided single-element focused ultrasound transducer (Device); Definity (Drug); Magnetic Resonance Imaging (MRI) with or without gadolinium contrast agents (Other); Positron Emission Tomography (PET) (Other); Amyvid (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Individuals With Successful Opening of the BBB |
5 | — |
| PRIMARY Total Number of Safety Events Related to Opening of BBB |
1 | — |
| SECONDARY Percent Change in Amyloid PET Signal Intensity |
-1.47 | — |
| SECONDARY Change in Mini-Mental State Examination (MMSE) Score |
-2.5 | — |
Summary
The purpose of this study is to test a new technique that may, in the future, help deliver medications to the brain of people with Alzheimer's disease. Participants in this study will undergo a focused ultrasound treatment to the brain, along with Magnetic Resonance Imagine (MRI) and Positron Emission Tomography (PET) scans.
Eligibility Criteria
Inclusion Criteria
- 50 years of age or older.
- Diagnosis of early Alzheimer's disease (AD) or mild cognitive impairment (MCI) at minimum. All following criteria must be met:
- Probable MCI or AD consistent with criteria outlined in (McKhann et al 2011, Petersen et al 2018).
- Mini Mental State Examination (MMSE) score between 12 and 26.
- Modified Hachinski Ischemia Scale (MHIS) score of 140 mmHg).
- Abnormal coagulation profile, e.g. hemophilia A or B.
- Coagulopathy or under anticoagulant therapy.
- History of stroke or cardiovascular disease.
- Active/detectable gingivitis, herpes simplex, hepatitis, tuberculosis, and minor skin or respiratory infections.
- History of seizure disorder.
- History of asthma or allergies to food or medication with significant symptoms in past 3 years.
- Severe brain atrophy.
- Inability to comply with the procedures of the protocol, including follow-up MRI scans.
- Pregnancy or lactation.
- Impaired renal function with estimated glomerular filtration rate (eGFR) 4 lobar microbleeds, and no siderosis or macrohemorrhages.
- Tumors or space occupying lesions.
- Meningeal enhancements.
- Intracranial hypotension.
Data sourced from ClinicalTrials.gov (NCT04118764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.