Ultrasound may help Alzheimer's drug reach the brain
NCT ID NCT06585384
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether it is safe to combine a drug called etanercept with repeated ultrasound sessions to temporarily open the blood-brain barrier in people with mild Alzheimer's disease. The goal is to let more of the drug reach the brain to reduce inflammation. Only 5 participants will be enrolled to check for side effects.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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: * Positive diagnosis of Alzheimer's disease according to IWG2 criteria * Biological profile in favour of Alzheimer's disease * Age ≥ 50 years and ≤ 85 years * Affiliated or beneficiary of a social insurance scheme * Patient suffering from mild AD with little or no impact on autonomy, MMSE score ≥20 at inclusion * Fazekas score \<=1 * Presence of a family or a person at home who can monitor the occurrence of adverse events * Sufficient command of the French language to take neuropsychological tests. * Have undergone a full neuropsychological assessment within 6 months. * If anticholinesterase treatment, stability of treatment for at least three months. * Signed, free and informed consent from the patient and the trusted support person. Exclusion Criteria: * Patient previously treated with anti-TNF alpha (e.g. etanercept). * Other cause of major neurocognitive disorder. * Participation in another drug study * Absolute contraindication to MRI (e.g. pacemaker, implantable stimulator, intra-orbital metallic foreign body); * Contraindication to lumbar puncture. * History of bleeding diathesis; * Severe chronic respiratory disease; * Patient on anticoagulant therapy * Right-to-left shunt, severe pulmonary arterial hypertension; * Known cerebral vasculopathy; (Fazekas greater than 1), sequelae of ACI. * Treatment with Anakinra, abatacept or sulfasalazine. * Patients who have undergone major surgery within 28 days of the first day of the study. * Allergy to gadolinium, or any contraindication to contrast products used for brain imaging (in particular severe renal insufficiency with a glomerular filtration rate \<30 ml / min / 1.73 m2). * Allergy to xylocaine * Epilepsy or drugs that lower the epileptogenic threshold (see Appendix 6). * Major depressive syndrome despite appropriate treatment and/or psychotic symptoms (according to DSM IV); * MRI characteristic of an active or acute neurological process (infection, tumour) or macro-haemorrhage. * Non-menopausal women * Patient benefiting from a legal protection measure other than guardianship or curatorship. * Optic neuritis * Manifestations of multiple sclerosis * Live vaccinations (yellow fever, BCG) within 4 weeks of starting etanercept treatment. * History of hepatitis B or C * Patients with recent acute coronary syndrome or unstable ischaemic heart disease. * History of recurrent or chronic infections, or a predisposing condition such as severe or poorly controlled diabetes. * Patients who have undergone major surgery within 28 days of the first day of the study. Contraindications related to etanercept : * Hypersensitivity to etanercept or to any of the excipients of Benepali * Sepsis or risk of sepsis * Active infection including chronic or localised infections. Contraindications associated with SonoVue (ultrasound contrast medium) * Hypersensitivity to Sonovue. * Right-to-left shunt * Severe PAH (pulmonary arterial pressure greater than 90 mmHg) * Uncontrolled hypertension * Respiratory distress syndrome * Conditions suggesting cardiovascular instability for which dobutamine is contraindicated
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fondation Adolphe de Rothschld
RECRUITINGParis, 75019, France
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