Could sound waves help Alzheimer's drugs work better?
NCT ID NCT05469009
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using focused ultrasound to temporarily open the blood-brain barrier can safely help standard antibody therapy reach the brain in people with mild Alzheimer's or mild cognitive impairment. About 15 participants will receive the combined treatment. The goal is to see if this approach is safe and feasible, not yet to prove it works.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2022
- Expected to finish
-
Jul 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
50 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Able and willing to give informed consent * Probable mild cognitive impairment due to AD * Modified Hachinski Ischemia Scale (MHIS) score of \<= 4 * Mini Mental State Exam (MMSE) scores \> 21+. * Short form Geriatric Depression Scale (GDS) score of \<= 7 * Amyloid PET scan consistent with the presence of β-amyloid (A+) * Able to communicate sensations during the Exablate MRgFUS procedure * Able to attend all study visits (i.e., life expectancy of 1 year or more) Exclusion Criteria: * MRI findings: * Significant cardiac disease or unstable hemodynamic status * History of a liver disease, bleeding disorder, coagulopathy or a history of spontaneous hemorrhage * Known cerebral or systemic vasculopathy * Significant depression (GDS \> 7) and/or at potential risk of suicide (C-SSRS \> 2) * A severity score of 2 or more on any of the 'Delusions', 'Hallucinations' or 'Agitation/Aggression' subscales of the Neuropsychiatry Inventory (NPI-Q) * Known sensitivity/allergy to gadolinium(gadobutrol), DEFINITY or its components, or 18F-florbetaben. * Known hypersensitivity to DEFINITY or its components. * Any contraindications to MRI scanning * Untreated, uncontrolled sleep apnea * History of untreated or uncontrolled seizure disorder or epilepsy. * Impaired renal function * Does not have a reliable caregiver * Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research. * Respiratory: chronic pulmonary disorders * History of clinically significant recent drug or alcohol use disorder who may be at higher risk for seizure or infection. * Positive human immunodeficiency virus (HIV) which can lead to increased entry of HIV into the brain parenchyma leading to HIV encephalitis. * Potential blood-borne infections, which can lead to increased entry to brain parenchyma leading to meningitis or brain abscess.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Alzheimer disease 1 are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
West Virginia University Rockefeller Neuroscience Institute
Morgantown, West Virginia, 26506, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Walking memory tests may reveal early Parkinson's clues
- Can tango rewire the brain? dance program tested for Parkinson's and dementia
- Can tiny bursts of baduanjin exercise sharpen a fading memory?
- Can pool workouts plus brain games sharpen memory in aging veterans?
- Can home exercise keep older adults with cognitive frailty on their feet?
- A new roadmap to predict Alzheimer's before memory fails