euroEPO in mild-moderate Alzheimer's disease

Phase 3

Recruiting

• Conditions: Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; mild-moderate Alzheimer's disease; Alzheimer Disease; Brain Diseases; Mental Disorders; Dementia; Neurodegenerative Diseases

• Registration Number: RPCEC00000409
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-20
• Last Update Posted: 19 August 2024
• Study Completion: 2025-05-30
• Results First Posted: 2025-09-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 413

Inclusion Criteria

1. Patients and/or caregivers who give their consent to participate in the study by signing the informed consent form.
2. Patient with a caregiver physically and mentally able to understand the study and willing to collaborate with the research.
3. Patients aged = 50 years.
4. Patients with GDS from 3 to 5 points, inclusive.
5. Patients with a CDR of 1 to 2 points, inclusive.
6. ADAScog11 score from 16 to 30 points, inclusive.
7. Patients with patent airways.

Exclusion Criteria

1. Medical condition (not Alzheimer's disease) that may be contributing to cognitive impairment in the subject (substance abuse, AIDS, syphilis, stroke or other cerebrovascular disease, head trauma, brain tumor, psychiatric illness).
2. History of unstable angina, acute myocardial infarction, cancer, Parkinson's disease, coagulation disorders, anemia, and chronic/decompensated liver or kidney disorders.
3. Any contraindication that does not allow MRI, SPECT-CT or PET-CT to be performed.
4. Subjects receiving treatment with antipsychotics, barbiturates, monoamine oxidase inhibitors, benzodiazepines and antidepressants, at doses that may compromise neuropsychological tests.
5. Patients who are receiving any of the medications approved for Alzheimer's disease (donepezil, rivastigmine, galantamine, memantine, aducanumab, NeuralCIM)
6. Patients with a history of hypersensitivity to hr-EPO or any component of the product.
7. Patients with known sensitivity to Donepezil hydrochloride, piperidine derivatives or some of the excipients used in the formulation.
8. Alcoholism.
9. Patients receiving treatment with anticoagulants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ADAScog11 (10-15 points: mild cognitive impairment. 16-24 points: mild stage. 25-30 points: moderate stage. 31-45 points: moderate-severe stage. > 45 points : severe stage). Measurement time: Baseline (before starting treatment), weeks 52 and 78.