euroEPO in patients with Mild-Moderate Alzheimer's disease

Phase 2

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

• Registration Number: RPCEC00000232
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study Completion: 2021-09-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

1- Patients with ages = to 50 years.
2- Patients with GDS between 2 to 4 points.
3- Patients with permeable airways.
4- Patients (or tutor, if the patient can not) grant consent to participate in the study by signing the informed consent model.
5- Patient with caregiver or legal tutor physically and mentally willing to collaborate with the investigation.

Exclusion Criteria

1- Negative patient or caregiver (if the patient is incapacitated) to participate in the study.
2- Evident mental disability or other limitation that prevents the patient or caregiver from signing their consent or hindering the study evaluations.
3- Patients with neurological symptoms or signs that suggest another cause of dementia.
4- Skull trauma or recent intracranial surgery.
5- Clotting disorders known.
6- Patients where coexistence of another disease or condition that may lead to significant disability (cancer, septic embolism, endocarditis, myeloproliferative disease, creatinine> 3 mg / dl (265µmol / L), hyperkalemia> 5.0 mmol / L, chronic/severe liver or kidney or heart disorders.
7- Patients with a history of hypersensitivity to EPO-hr.
8- Patients with known allergy to any ingredients of the product.
9- Patients who present nasal irritation (sneezing) or a runny nose before starting treatment.
10- Patients who present asthma attack at the begining of the treatment.
11- Patients receiving treatment with AChE-I or Memantine.
12- Patients receiving treatment with psychoactive that compromise the clinical trial results or neuropsychological tests.
13- Patients with a history of alcoholism and / or drug dependence.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ADAS-cog11 Value (ADAS-cog11 scale). Measuring time: at 6 months, 12 months (If the probability of success at 6 months is low).