euroEPO in mild-moderate Alzheimer's disease amnesic variant

Phase 4

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

• Registration Number: RPCEC00000410
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-22
• Last Update Posted: 19 August 2024
• Study Completion: 2026-01-30
• Results First Posted: 2026-12-31

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 1456

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 physically and mentally trained caregiver to understand the study and willing to collaborate with the research.
3.- Patients aged = 19 years.
4.- Patients with GDS from 3 to 5 points.
5.- Patients with CDR of 1 to 2 points.
6.- ADAScog11 score from 16 to 30 points.
7.- Patients with permeable 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).
2. Patients with vascular dementia will be excluded, according to the criteria of the National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et 1'Enseignement en Neurosciences) (NINDS-AIREN).
3. Unstable/uncontrolled psychiatric illness (example: major depression, schizophrenia, bipolar disorder).
4. History of unstable angina, acute myocardial infarction, cancer, Parkinson's, kidney disease, liver disease, coagulation disorders, anemia.
5. Subjects receiving treatment with antipsychotics, barbiturates, monoamine oxidase inhibitors, benzodiazepines and antidepressants, at doses that may compromise neuropsychological tests.
6. Patients receiving any of the approved medications for Alzheimer's disease (donepezil, rivastigmine, galantamine, memantine, aducanumab, neuroEPO)
7. Patients with a history of hypersensitivity to hr-EPO or any component of the product.
8. Patients with nasal irritation (sneezing) or runny nose before starting treatment.
9. Alcoholism.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ADAScog11 (10-15 points: mild cognitive impairment (MCI). 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, 78 and 104.