NCT07178678

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Detailed description

The objective of the trial will be to assess the safety and efficacy of NeuroEPO plus standard of care treatment in participants with mild to moderate AD when delivered with a cannula attached to a syringe. A previous Phase II-III clinical trial in Cuba showed excellent safety and efficacy of NeuroEPO compared to no treatment in mild to moderate AD patients. In this clinical trial, NeuroEPO was administered intranasally with an insulin syringe. In the proposed phase II clinical trial, we will assess the safety and efficacy of 0.5 mg of NeuroEPO administered intranasally using a cannula attached to a syringe while the participant is in the Kaiteki position. Participants will be divided into two cohorts, involving 60 NeuroEPO-treated, and 30 placebo-treated participants for a total of 90 participants. NeuroEPO or the placebo will be administered three times a week for 52 weeks. An updated ADAScog test (ADAScog13) will be used as the primary outcome. The ADAScog13 test will be administered along with the other cognitive tests, Global Deterioration Scale (GDS), the Clinical Dementia Rating (CDR) the Mini Mental State Examination (MMSE), Alzheimer's Disease Co-operative Study Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory Questionnaire (NPI-Q), Quality of Life in Alzheimer's Disease (QoL-AD) prior to starting treatment and one year after treatment. β-amyloid, phosphoTau, and ApoE biomarkers and the additional neuropsychological tests will be used as secondary outcomes. Labs, vitals and adverse events will be collected prior to the start of the trial, at 1, 3, 6, and 12 months to monitor for safety. Participants who consent to MRI and/or PET will be administered MRI and PET scans twice in the trial, once when the trial participant commences the trial and once when they conclude the trial. At 12 months final evaluations will be collected for cognitive tests and for those participants who consented to MRI and/or PET a second MRI and/or PET scan will be taken.

Conditions

• Mild Alzheimer's Disease
• Moderate Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	NeuroEPO	0.5 mg of NeuroEPO will be administered intranasally three times a week for 52 weeks.
DRUG	Placebo	250 µL of placebo will be administered to intranasally to each nostril three times a week for 52 weeks.

Timeline

• Start date: 2025-11-01
• Primary completion: 2030-03-01
• Completion: 2030-12-01
• First posted: 2025-09-17
• Last updated: 2025-09-17

Locations

1 site across 1 country: Canada