Not Yet RecruitingPhase 2

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

Canada90 participantsStarted 2025-11

Plain-language 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

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ing…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1NeuroEPO is being tested in a Phase 2 trial, which means it's still in relatively early stages of human testing — what do we know so far about its safety profile, and what unknowns should I be aware of before considering it?
2The trial is listed as 'not yet recruiting,' so can you help me find out when it might open and whether it would realistically be an option given where I am in my disease progression right now?
3The trial is enrolling people with mild to moderate Alzheimer's disease — given my current stage, do I fall within the range this study is targeting, and would my other health conditions or medications likely affect whether I'd be considered?
4The main thing this trial is measuring is the ADAS-cog13, a cognitive assessment scale — what does that mean in practical terms, and would any improvement on that scale translate into something I'd actually notice in daily life?
5Compared to approved Alzheimer's treatments already available, what are the potential advantages and drawbacks of participating in an experimental Phase 2 study like this one instead of — or alongside — standard care?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog13)

Timeframe: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks

Trial details

NCT IDNCT07178678

SponsorUniversity of Saskatchewan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-03

View on ClinicalTrials.gov More Mild Alzheimer's Disease trials