NCT07178678Not yet recruitingPhase 2
Evaluation of the Safety and Efficacy of NeuroEPO in Subjects With Mild to Moderate Alzheimer's Disease
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
Source: ClinicalTrials.gov · Last updated 17 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 25 Nov 2024
- Start date
- Nov 2025
- Primary completion date
- Mar 2030
- Lead sponsor
- University of Saskatchewan
- Diseases
- Alzheimer disease
- NCT number
- NCT07178678
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From Nov 2025 to the primary completion date, Mar 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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.
Lab values
- 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).
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Saskatchewan Coordinator of this site? Confirm its status | Saskatoon | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.