Status:
COMPLETED
Non-invasive Blood-brain Barrier Opening in Alzheimer's Disease Patients Using Focused Ultrasound
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50+ years
Phase:
NA
Brief 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 focuse...
Detailed Description
Central nervous system disorders are currently being symptomatically treated since the molecular events provoking their onset have not been yet identified. Drug delivery techniques have to overcome th...
Eligibility Criteria
Inclusion
- 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 \<= 4
- Short form Geriatric Depression Scale (GDS) score of \<= 6.
- PET scan confirming amyloid plaque load using Amyvid (18F-Florbetapir).
- Ability to provide informed consent.
Exclusion
- Contraindication for Magnetic Resonance Imaging (MRI).
- Contra-indication history or hypersensitivity to MRI contrast agents (e.g., Dotarem) or microbubbles (e.g., Definity).
- Prior brain surgery, including deep brain stimulation.
- Metallic implants.
- Moderate or severe uncontrolled hypertension (systolic blood pressure \> 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) \<30 mL/min/1.73m2 provided by a standard blood test at maximum 2 weeks prior to the ultrasound treatment.
- Active infection/inflammation.
- Acute or chronic hemorrhages, i.e. \> 4 lobar microbleeds, and no siderosis or macrohemorrhages.
- Tumors or space occupying lesions.
- Meningeal enhancements.
- Intracranial hypotension.
Key Trial Info
Start Date :
August 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04118764
Start Date
August 6 2020
End Date
September 28 2022
Last Update
August 26 2024
Active Locations (1)
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1
Columbia University Irving Medical Center/NYPH
New York, New York, United States, 11021