Non-invasive Blood-brain Barrier Opening in Alzheimer's Disease Patients Using Focused Ultrasound
Completed · Not applicable
Conditions studied: Alzheimer Disease
In brief
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.
Key facts
- Study ID
- NCT04118764
- Run by
- Columbia University
- People needed
- 6
- Starts
- 2020-08-06
- Expected to finish
- 2022-09-28
- Last updated by the study team
- 2024-08-26
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Columbia University Irving Medical Center/NYPH — New York, New York, United States
Full record on ClinicalTrials.gov
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