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

NCT07178678 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CBIRD.NeuroEPO.20210803
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Mild Alzheimer's Disease; Moderate Alzheimer's Disease

Keywords

Alzheimer's Disease; NeuroEPO; EPO; ADAS-cog13

Outcome Measures

Primary Outcomes (1)

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

  The ADAS-cog13 is a brief battery of cognitive tests that assesses learning and memory, language production, language comprehension, constructional praxis, ideational praxis, and orientation. The ADAS-Cog is an in-person examiner-administered, structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained. The ADAS-cog13 scale is scored from 0-85, with higher scores indicating a worse outcome.

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

Secondary Outcomes (9)

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

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

• Mini-Mental State Exam (MMSE)

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

• Neuropsychiatric inventory (NPI)

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

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

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

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

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

Other Outcomes (1)

• Amyloid-PET (Vizamyl)

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

Study Arms (2)

NeuroEPO + standard of care

EXPERIMENTAL

NeuroEPO + standard of care for Alzheimer's Disease

Drug: NeuroEPO

Placebo + standard of care

PLACEBO COMPARATOR

Placebo + standard of care for Alzheimer's disease

Drug: Placebo

Interventions

NeuroEPO DRUG

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

NeuroEPO + standard of care

Placebo DRUG

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

Placebo + standard of care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Saskatchewan: lead
• Center of Molecular Immunology, Cuba: collaborator

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N5E5, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: One group will receive NeuroEPO and one group will receive a placebo.

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: September 17, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

CA (1)