Status:
NOT_YET_RECRUITING
Evaluation of the Safety and Efficacy of NeuroEPO in Subjects With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
University of Saskatchewan
Collaborating Sponsors:
Center of Molecular Immunology, Cuba
Conditions:
Mild Alzheimer's Disease
Moderate Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to test if NeuroEPO improves or maintains cognition in adults with mild to moderate Alzheimer's Disease using a cannula attached to a syringe for delivery. It will a...
Detailed Description
The objective of the trial will be to assess the safety and efficacy of NeuroEPO plus standard of care treatment in participants with mild to moderate AD when delivered with a cannula attached to a sy...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07178678
Start Date
November 1 2025
End Date
December 1 2030
Last Update
September 17 2025
Active Locations (1)
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1
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N5E5