Evaluation of the Safety and Efficacy of NeuroEPO in Subjects With Mild to Moderate Alzheimer's Disease

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 also learn the safety of NeuroEPO. The main questions it aims to answer are: Does NeuroEPO lower or maintain a person's cognition who has been diagnosed with Alzheimer's Disease? What medical problems do participants have when taking NeuroEPO? Researchers will compare NeuroEPO to a placebo (a look-alike substance that contains no drug) to see if NeuroEPO works to treat Alzheimer's Disease. Participants will: Take NeuroEPO or a placebo three times a week for one year Visit the clinic to determine eligibility, for cognitive testing and blood tests at the start and end of the trial and at 1, 2, 6 and 12 months for check ups and blood collection

Interventions

• NeuroEPO · DRUG

  0.5 mg of NeuroEPO will be administered intranasally three times a week for 52 weeks.

• Placebo · DRUG

  250 µL of placebo will be administered to intranasally to each nostril three times a week for 52 weeks.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* 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 Criteria:

* 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.

Sites (1)

• University of Saskatchewan, Saskatoon, Saskatchewan, Canada