NeuroEPO for Alzheimer's Disease

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Saskatchewan

Must not be taking: Anticoagulants, Psychoactives

Disqualifiers: Neurological symptoms, Skull trauma, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called NeuroEPO for individuals with mild to moderate Alzheimer's Disease. The goal is to determine if NeuroEPO can improve or maintain memory and thinking skills. Participants will receive either NeuroEPO or a placebo (a look-alike with no active drug) to compare effects. Ideal participants have Alzheimer's without recent nose surgeries or severe health conditions, and they must have a caregiver willing to assist with the study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stop taking anticoagulants and certain psychoactive medications. If you are on AChE-I or Memantine, you must be stable on these for at least 12 weeks before joining the trial.

Is there any evidence suggesting that NeuroEPO is likely to be safe for humans?

Research has shown that NeuroEPO, tested in early studies, seems to protect brain cells. This treatment may help alleviate Alzheimer's symptoms by preventing brain damage and inflammation. Importantly, studies have not identified any major safety concerns for those using NeuroEPO.

As this treatment enters the second phase of testing, some safety information is already available from earlier studies. So far, patients have tolerated it well, with no serious side effects reported. However, researchers continue to monitor closely for any medical issues as more participants join the trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

NeuroEPO is unique because it offers a new approach to treating Alzheimer's disease by utilizing a form of erythropoietin (EPO) that is designed to penetrate the brain more effectively. Unlike current treatments that primarily focus on managing symptoms with medications like cholinesterase inhibitors or NMDA receptor antagonists, NeuroEPO targets neural protection and regeneration. Researchers are excited about NeuroEPO because it could potentially slow the progression of the disease and improve cognitive function by directly supporting brain cell health, offering hope beyond symptom management.

What evidence suggests that NeuroEPO might be an effective treatment for Alzheimer's Disease?

Research has shown that NeuroEPO, which participants in this trial may receive alongside standard care, might benefit individuals with mild to moderate Alzheimer's Disease. In some studies, patients who took NeuroEPO performed better on memory and thinking tests than those who took a placebo, a harmless pill with no active medicine. After 48 weeks, participants in these studies showed improvements in these tests. NeuroEPO also appears to slow the progression of Alzheimer's symptoms. It may work by stabilizing or slowing memory and thinking problems, offering hope for managing the condition. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with mild to moderate Alzheimer's Disease. Participants will receive NeuroEPO or a placebo via a cannula three times weekly for one year. They must visit the clinic for tests and check-ups at specified intervals.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive NeuroEPO or placebo three times a week for 52 weeks

52 weeks

Visits at start, 1, 2, 6, and 12 months for cognitive testing and blood tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Final evaluations at 12 months

What Are the Treatments Tested in This Trial?

Interventions

• NeuroEPO

Trial Overview The trial aims to determine if NeuroEPO can improve or maintain cognition in Alzheimer's patients compared to a placebo. It involves regular cognitive testing and blood tests over the course of the study.

How Is the Trial Designed?

Group I: NeuroEPO + standard of care Experimental Treatment 1 Intervention

NeuroEPO + standard of care for Alzheimer's Disease

Group II: Placebo + standard of care Placebo Group 1 Intervention

Placebo + standard of care for Alzheimer's disease

Who Is Running the Clinical Trial?

University of Saskatchewan

Lead Sponsor

Trials

261

Recruited

156,000+

Center of Molecular Immunology, Cuba

Collaborator

Trials

1

Recruited

30+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38093366/

NeuroEPO plus (NeuralCIM®) in mild-to-moderate ... NeuroEPO plus treatment induced a statistically significant improvement in some of clinical secondary outcomes vs. placebo including CIBIC+, GDS ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07178678

Evaluation of the Safety and Efficacy of NeuroEPO ... The goal of this clinical trial is to test if NeuroEPO improves or maintains cognition in adults with mild to moderate Alzheimer's Disease ...

3. alzres.biomedcentral.com alzres.biomedcentral.com/articles/10.1186/s13195-023-01356-w

NeuroEPO plus (NeuralCIM®) in mild-to-moderate ... Among participants with mild-moderate Alzheimer's disease clinical syndrome, neuroEPO plus improved the cognitive evaluation at 48 weeks, with a ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41124311/

NeuroEPO plus (NeuralCIM®) in Alzheimer's disease ConclusionsSubjects who continued or started treatment with neuroEPO plus stabilized or slowed down the progression of the disease. These ...

5. mdpi.com mdpi.com/2076-3921/14/6/710

Subchronic Intranasal Administration of NeuroEPO ... Clinical studies revealed that the intranasal administration of NeuroEPO to patients with Alzheimer's and Parkinson's diseases slows cognitive declines and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07178678

Evaluation of the Safety and Efficacy of NeuroEPO ... The goal of this clinical trial is to test if NeuroEPO improves or maintains cognition in adults with mild to moderate Alzheimer's Disease ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10716956/

NeuroEPO plus (NeuralCIM®) in mild-to-moderate ... NeuroEPO plus prevents oxidative damage, neuroinflammation, apoptosis and cognitive deficit in an Alzheimer's disease (AD) models. The aim of ...

8. ctv.veeva.com ctv.veeva.com/study/evaluation-of-the-safety-and-efficacy-of-neuroepo-in-subjects-with-mild-to-moderate-alzheimers-dise

Evaluation of the Safety and Efficacy of NeuroEPO in Subjects ... The goal of this clinical trial is to test if NeuroEPO improves or maintains cognition in adults with mild to moderate Alzheimer's Disease ...

9. researchgate.net researchgate.net/publication/376585719_NeuroEPO_plus_NeuralCIMR_in_mild-to-moderate_Alzheimer's_clinical_syndrome_the_ATHENEA_randomized_clinical_trial

(PDF) NeuroEPO plus (NeuralCIM®) in mild-to-moderate ... NeuroEPO plus prevents oxidative damage, neuroinflammation, apoptosis and cognitive deficit in an Alzheimer's disease (AD) models. The aim of ...