NCT07178678 · Phase 2 · NOT YET RECRUITING
Evaluation of the Safety and Efficacy of NeuroEPO in Subjects With Mild to Moderate Alzheimer's Disease
This trial tests whether NeuroEPO, a nasal-delivered form of erythropoietin, helps people with mild to moderate Alzheimer's keep their thinking skills steadier than a placebo over one year. Participants take it three times a week. Researchers also track side effects. It is a Phase 2 trial, testing whether it works and is safe, not yet proven or approved.
You may qualify if
- Patients >= 50 years of age, to reflect the population that will be treated and to avoid younger populations who may be suffering dementia from a cause other than Alzheimer's Disease.
- Patients with Global Deterioration Scale (GDS) between 3 to 5 points (inclusive).
- Clinical Dementia Rating (CDR) - GS score 1-2 at screening.
- Patients with permeable airways.
- Patients (or caregiver, if the patient cannot) grant consent to participate in the study by signing the informed consent form.
- Patient with caregiver is physically and mentally willing to collaborate with the investigation.
- Mini-Mental State Examination (MMSE) score between 14 and 26 (inclusive) at screening
You're excluded if
- Evident mental disability or other limitation that prevents the patient or caregiver from administering the study evaluations.
- Patients with neurological symptoms or signs that suggest another cause of dementia.
- Skull trauma or recent intracranial surgery.
- Known clotting disorders.
- Use of anticoagulants, a medication to prevent harmful blood clots (warfarin, heparin or NOAC).
- Patients where coexistence of another disease or condition that may lead to significant disability (cancer, septic embolism, endocarditis, myeloproliferative disease, creatinine> 3 mg / dl (265µmol / L), hyperkalemia > 5.0 mmol / L, chronic/severe liver or kidney or heart disorders.
- Patients with a history of hypersensitivity to rhEPO.
- Patients with known allergy to any ingredients of the product.
- Patients who present nasal irritation (sneezing) or a runny nose before starting treatment.
- Patients who present asthma attack at the beginning of the treatment.
- Patients receiving treatment with AChE-I or Memantine who are not stable for 12-weeks prior to screening.
- Patients receiving treatment with psychoactive that can compromise the clinical trial results or neuropsychological tests.
- Patients with a history of alcoholism and/or drug dependence.
- Patients with chronic rhinosinusitis.
- Have a history of abnormal nasal or sinus symptoms.
- Have prior skull fracture or abnormality (nasal defect, deviated septum).
- Have recent nasal trauma (fracture in the last 2 months).
- Have any prior sinus or nose surgery (rhinoplasty).
- Have known bleeding problem (low platelets-thrombocytopenia), recurrent nose bleeds (>3 year).
- Have acute inflammation inside the nose.
- Congenital cranial facial disorders.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-09-17