Tests NeuroEPO against a placebo in people with early Alzheimer's disease
Tests NeuroEPO or a placebo in adults with mild or moderate Alzheimer's disease.
Plain-language title generated from the registry record
Registry title: Evaluation of the Safety and Efficacy of NeuroEPO in Subjects With Mild to Moderate Alzheimer's Disease
Key facts
- Where
- Saskatoon, CanadaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 50 or older with mild to moderate Alzheimer's disease. They would take NeuroEPO or a placebo three times a week for one year.
- Age
- 50 years or older.
- Sex
- All sexes can join.
- Disease stage
- Mild to moderate Alzheimer's disease. Global Deterioration Scale 3 to 5, Clinical Dementia Rating 1-2, and Mini-Mental State Examination score 14 to 26 at screening.
- Earlier treatment
- People taking AChE-I or Memantine must have been stable on it for 12 weeks before screening. Use of warfarin, heparin or NOAC anticoagulants is not allowed.
Main reasons for not taking part
- Signs that suggest another cause of dementia
- Known clotting or bleeding problems, or use of anticoagulants
- Chronic rhinosinusitis, nose or sinus problems, or past nose or sinus surgery
- Allergy to rhEPO or any ingredient of the product
- Severe liver, kidney or heart disease, cancer, or a history of alcoholism or drug dependence
Read by machine on 9 November 2026.
Where in Canada
- University of SaskatchewanSaskatoon, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Saskatchewan
- Trial code
- NCT07178678
- Record updated
- 17 September 2025
- Original description
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:Read full original descriptionShow less
A Phase II, Blinded, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of NeuroEPO in Subjects With Mild to Moderate Alzheimer's Disease Who Are Receiving Standard of Care Treatment
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
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: Skull trauma or recent intracranial surgery; Use of anticoagulants, a medication to prevent harmful blood clots (warfarin, heparin or NOAC); 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; Have prior skull fracture or abnormality (nasal defect, deviated septum); Have any prior sinus or nose surgery (rhinoplasty); Patients with neurological symptoms or signs that suggest another cause of dementia; Known clotting disorders; Patients with a history of hypersensitivity to rhEPO; Patients with known allergy to any ingredients of the product; Patients with a history of alcoholism and/or drug dependence; Have a history of abnormal nasal or sinus symptoms; Congenital cranial facial disorders; 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; Have known bleeding problem (low platelets-thrombocytopenia), recurrent nose bleeds (>3 year); Evident mental disability or other limitation that prevents the patient or caregiver from administering the study evaluations; 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 with chronic rhinosinusitis; Have recent nasal trauma (fracture in the last 2 months); Have acute inflammation inside the nose.