Not 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

Lead sponsor

University of Saskatchewan

Asset

NeuroEPO

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•MMSE 14-26•Study partner/caregiver required

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCBIRD.NeuroEPO.20210803

NCT IDNCT07178678

Timeline

Milestones

Study first posted2025-09-17actual

Last update posted2025-09-17actual

Study start2025-11estimated (month precision)

Primary completion2030-03estimated (month precision)

Study completion2030-12estimated (month precision)

Assets

Drug assets

NeuroEPO

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Amyloid biomarkers

Memory

Function / daily living

Behavior / neuropsychiatric

Tau biomarkers

Neuroimaging

Other (unclassified)

Global cognition

3 endpoints

Primary/protocol endpoint

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

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

ADAS-Cog

descriptive

Secondary/protocol endpoint

Clinical Dementia Rating scale Sum of Boxes (CDR-SB)

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

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Secondary/protocol endpoint

Mini-Mental State Exam (MMSE)

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

Mini-Mental State Examination (MMSE)

concentration, descriptive

Memory

1 endpoint

Secondary/protocol endpoint

Quality of Life in Alzheimer's disease (QoL-AD).

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

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Alzheimer's Disease Cooperative Study - Activities of daily living (ADCS-ADL).

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

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Neuropsychiatric inventory (NPI)

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

Neuropsychiatric Inventory (NPI)

event count, event

Amyloid biomarkers

2 endpoints

Secondary/protocol endpoint

Blood analysis of Amyloid (Aβ1-42/Aβ1-40 ratio)

Time frame:This test will be be done prior to treatment and at the end of treatment at 52 weeks.

ratio, descriptive

Other/protocol endpoint

Amyloid-PET (Vizamyl)

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

descriptive

Tau biomarkers

1 endpoint

Secondary/protocol endpoint

Blood analysis of phosphoTau (pTau)

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

Phosphorylated tau 217 (p-tau217)

descriptive

Neuroimaging

1 endpoint

Secondary/protocol endpoint

whole brain volume MRI (vMRI)

Time frame:The scan will be done prior to the start of treatment and at the end of treatment at 52 weeks

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Global Dementia Scale (GDS)

Time frame:This test will be given prior to the start of treatment and at the end of treatment at 52 weeks.

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.