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

NCT07178678 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-09-17

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Center of Molecular Immunology, Cuba

    collaborator OTHER

  • University of Saskatchewan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2030-03-31
Completion
2030-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07178678 on ClinicalTrials.gov