Status:
NOT_YET_RECRUITING
Safety of a Strategy Combining Etanercept Administration with Repeated Contrast Ultrasound in Patients with Alzheimer's Disease
Lead Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE1
Brief Summary
Alzheimer's disease (AD) is a clinico-pathological entity combining multiple and varied neuropathological lesions with characteristic abnormal accumulations (amyloid Beta (Aβ) plaques and neurofibrill...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06585384
Start Date
March 1 2025
End Date
September 1 2027
Last Update
October 16 2024
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