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

View full record on ClinicalTrials.gov

All APOE4 clinical trials