NeuroEPO in mild-moderate Alzheimer's disease amnesic variant

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Evaluation of the effectiveness and safety of the administration of neuroEPO in patients with mild-moderate Alzheimer's disease phenotype amnesic variant

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM), Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Saily

Last name:

Sosa Perez

Medical Specialty :

Second degree specialist in Internal Medicine

Affiliation:

Ivan Portuondo Hospital

Postal address:

street 37 between 72 and 74, San Antonio de los Baños

City:

Artemisa

Country:

Cuba

Zip Code:

32500

Telephone:

+53-47383146

Email address:

zailysosaz@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Pinar del Rio, Abel Santamaria Hospital, Dr. Antonio Javier Garcia Medina, 1st Degree Specialist in Neurology

Matanzas, Faustino Perez Hospital, Dr. Adolfo Valhuerdi Cepero, 1st Degree Specialist in Internal Medicine

Cienfuegos, Gustavo Aldereguia Lima Hospital, Dr. Tomas Castillo Juit, 1st Degree Specialist in Neurology

Villa Clara, Arnaldo Milian Castro Hospital, Dra. Marbelys Guevara Rodriguez, 1st Degree Specialist in Neurology

Sancti Spiritus, Camilo Cienfuegos Hospital, Dr Dimitri Dueñas Valdivia, 1st Degree Specialist in MGI

Camagüey, Manuel Ascunce Hospital, Dra. Nayade Perez Rodríguez, 1st degree specialist MGI and Neurology

Ciego de Avila, Roberto Rodriguez Hospital, Dr. Hector Luis Salazar Ferrer, 1st degree specialist MGI and Neurology

Ciego de Avila , Antonio Luaces Hospital, Dr. Rolando Alvarez Llanes, 1st degree specialist MGI and Neurology

Las Tunas, Ernesto Guevara Hospital, Dra. Melitza de la Caridad Pupo Machado, 1st Degree Specialist in Neurology

Granma, Celia Sanchez Manduley Hospital, Dr. Roberto Luis Lotti Mesa, 1st Degree Specialist in Neurology

Granma, Carlos M. de Cespedes Hospital, Dra. Mabel Rosa oduardo Aguilar, 2nd Degree Specialist in Neurology

Santiago de Cuba, Saturnino Lora Hospital, Dra. Elizabeth Colina Avila, 2nd Degree Specialist in Neurology

Santiago de Cuba, Juan Bruno Zayas Hospital, Dra. Monica Rodríguez Montalvan, 1st Degree Specialist in Neurology

Guantánamo, Agustino Neto Hospital, Dra. Niorvis Martin Abiague, 1st Degree Specialist in Neurology

Holguín, Lucía Íñiguez Hospital, Dr. Pedro Enrique Labrada Aguilera, 2nd Degree Specialist in Neurology

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

17/10/2022

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

mild-moderate Alzheimer's disease

Health condition(s) code:

Alzheimer Disease

Dementia

Brain Diseases

Central Nervous System Diseases

Nervous System Diseases

Tauopathies

Neurodegenerative Diseases

Neurocognitive Disorders

Mental Disorders

Intervention(s):

A single treatment group will be formed. Subjects will receive neuroEPO, 0.5 mg (equivalent 0.5 mL), administered nasally 3 times per week (Monday, Wednesday, and Friday), for 104 weeks. NeuroEPO is a nasal formulation (nasal drops). 0.25 mL is added to each nostril to obtain a total dose of 0.5 mL.

Intervention code:

Erythropoietin

Neuroprotective Agents

Administration, Intranasal

Intervention keyword:

NeuroEPO

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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.

Key secondary outcomes:

Efficacy related: 1.- Degree of dementia. Measured by GDS (1 Absence of cognitive deficit. 2 Very mild cognitive deficit, 3 Mild cognitive deficit, 4 Moderate cognitive deficit, 5 Moderately severe cognitive deficit, 6 Severe cognitive deficit, 7 Very severe cognitive deficit. Measurement time: start, weeks 52, 78 and 104. 2.- Classification of dementia by CDR (0: No deterioration.0.5: Doubtful deterioration.1: Mild deterioration.2: Moderate deterioration. 3: Severe deterioration.). Measurement time: start, weeks 52, 78 and 104. 3.- General cognitive status. Measured by MoCA (≥ 26 points: Normal, 25-22 points: MCI, 21-18 points: mild impairment, 17-14 points: moderate impairment, < 14 points: severe impairment. Measurement time: start, weeks 52, 78 and 104. 4.- Global assessment of the patient's condition. Measured by CIBIC plus (1 point: Marked improvement. 2 points: Moderate improvement. 3 points: Minimal improvement. 4 points: No change. 5 points: Minimal worsening. 6 points: Moderate worsening. 7 points: Marked worsening. Measurement time: weeks 52, 78 and 104. 5.- Validity index in the basic activities of daily life. Measured by Katz Index (A. Independent in all functions B. Independent in all functions except any one, C. Independent in all functions except in the bathroom and any other, D. Independent in all functions except in the bathing, dressing and any other, E. Independent in all functions except bathing, dressing, toileting and any other, F. Independent in all functions except bathing, dressing, toileting, mobility and any other , G. Dependent on all functions, H. Dependent on at least two functions, but not classifiable as C, D, E or F) . Measurement time: start, weeks 52, 78 and 104. 6.- Validity index in instrumental activities of daily living. Measured by Lawton Index (Female: 0-1 point Total Dependence, 2-3 points Severe, 4-5 points Moderate, 6-7 points mild, 8 points Autonomous. Male: 0 point Total Dependence, 1 point Severe, 2- 3 points Moderate, 4 points mild, 5 points Autonomous). Measurement time: start, weeks 52, 78 and 104. 7.- Psycho-behavioral manifestations. Measures by NPI (Maximum score 120 points. The higher the score, the worse the patient is). Measurement time: start, weeks 52, 78 and 104. 8.- Degree of depression. Measured by the Cornell scale (Less than 12 points: No depression. 12 to 24 points: Minor or mild depression. 25 or more points: Major depression). Measurement time: start, weeks 52, 78 and 104. Security related: 9.- Severity of the adverse event (serious, not serious). Measurement time start, weeks 52, 78 and 104. 10.- Type of adverse event (will classify the type of adverse event according to the categories established in Regulation 45 of 2007 of the CECMED). Measurement time start, weeks 52, 78 and 104. 11.- Intensity of the adverse event (mild, moderate, severe). Measurement time start, weeks 52, 78 and 104. 12.- Causality of the adverse event (definite, very likely, likely, possible, unlikely, unrelated, not evaluable). Measurement time start, weeks 52, 78 and 104. 13.- Attitude towards the drug (no changes, dose modification, temporary or definitive interruption). Measurement time start, weeks 52, 78 and 104. 14.- Outcome (recovered, recovered with sequelae requiring treatment, recovered with sequelae not requiring treatment, death). Measurement time start, weeks 52, 78 and 104. 15.- Hemoglobin (According to the values stipulated in each center). Measurement time: start, weeks 52, 78 and 104. 16.- Hematocrit (According to the values stipulated in each center). Measurement time: start, weeks 52, 78 and 104. 17.- Platelet count (According to the values stipulated in each center). Measurement time: start, weeks 52 and . 18.- White blood cell count (According to the values stipulated in each center). Measurement time: start, weeks 52, 78 and 104. 19.- Glycaemia (According to the values stipulated in each center). Measurement time: start, weeks 52, 78 and 104. 20.- Glutamic oxalacetic transaminase (GOT) (According to the values stipulated in each center). Measurement time: start, weeks 52, 78 and 104. 21.- Glutamic-pyruvic transaminase (GTP) (According to the values stipulated in each center). Measurement time: start, weeks 52, 78 and 104 . 22.- Cholesterol (According to the values stipulated in each center). Measurement time: start, weeks 52, 78 and 104. 23.- Triglycerides (According to the values stipulated in each center). Measurement time: start, weeks 52, 78 and 104. 24.- Creatinine (According to the values stipulated in each center). Measurement time: start, weeks 52, 78 and 104. 25.- Uric acid (According to the values stipulated in each center). Measurement time: start, weeks 52, 78 and 104.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

Target sample size:

1456

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Leslie

Last Name:

Perez Ruiz

Specialty:

Pharmaceutical Sciences, DrC

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 St. & 15th Ave. Siboney. Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72143202

Email :

leslie@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Saily

Last Name:

Sosa Perez

Specialty:

2nd degree specialist in Internal Medicine. MSc.

Affiliation:

Ivan Portuondo Hospital

Postal Address:

street 37 between 72 and 74, San Antonio de los Baños

City:

Artemisa

Country:

Cuba

Zip Code:

32500

Telephone:

+5347383146

Email :

zailysosaz@infomed.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Abel Santamaria Cuadrado General Teaching Hospital

Comandante Faustino Perez Hernandez Surgical Clinical Hospital

University of Medical Sciences of Cienfuegos

Arnaldo Milian Castro Provincial University Hospital

Camilo Cienfuegos Gorriarán Provincial Hospital

Manuel Ascunce Domenech Surgical Clinical Provincial Hospital

Roberto Rodriguez Provincial General Teaching Hospital

Dr. Antonio Luaces Iraola General Teaching Hospital

Dr. Ernesto Guevara de la Serna General Teaching Hospital

Celia Sanchez Manduley Teaching Surgical Clinical Hospital

Carlos Manuel de Cespedes Provincial General Hospital

Saturnino Lora Torres Surgical Clinical Provincial Hospital

Dr. Juan Bruno Zayas General Teaching Hospital

Dr. Agosthino Neto General Teaching Hospital

Lucia Iñiguez Landin Surgical Clinical Hospital

Status of evaluation:

In Evaluation

Status of evaluation date of Ethic Committee:

01/08/2022

Postal address of Ethic Committee :

Km 89 Carretera Central, Pinar del Río. CP. 20 200. Cuba

Carretera Central Km. 101. Matanzas. CP. 40 100. Cuba

Ave 5 de Septiembre Esquina 51ª. Cienfuegos. CP 55100. Cuba

Avenida “Arnaldo Milian Castro” e/ Circunvalacion y Doble Via. Villa Clara. CP. 50100. Cuba

Bartolomé Masó No. 128. Esquina Mirto. S. Spíritus. CP. 60 100. Cuba

Carretera Central Oeste Km 4 1/2. Camagüey. Cuba

Zayas s/n esquina Libertad. Morón. Ciego de Ávila. CP. 67 210. Cuba

Calle Máximo Gómez No. 257 entre 4ta y Onelio Hernández. Ciego de Ávila. CP. 65200. Cuba

Avenida 2 de Diciembre No. 1. La Tunas. CP. 75 100. Cuba

Avenida Camilo Cienfuegos Km 1. Vía Campechuela. Manzanillo. Granma. CP. 87 510. Cuba

Carretera Km 1. Vía Santiago de Cuba. CP. 85 100. Cuba

Avenida de Los Libertadores S/n entre 4ta y 6ta, Reparto Fomento. Santiago de Cuba. CP. 90100. Cuba

Carretera del Caney Esq 23 Pastorita Santiago de Cuba. CP. 90100. Cuba

5 Oeste entre 9 y 13 Norte. Guantánamo. CP. 95 100

Ave Celia Sánchez Manduley No. 1. Holguín. CP. 80100. Cuba

Telephone:

+53-48760102

+53-45256001

+53-43591100

+53-42270033

+53-41338001

+53-32282012

+53-33505598

+53-33226269

+53-31345012

+53-23571433

+53-23423321

+53-22626571 Ext 1221

+53-22642016 Ext 1009

+53-21381230

+53-24481013

Email:

dirhas@princesa.pri.sld.cu

direccionfaustinop.mtz@infomed.sld.cu

hospital@gal.sld.cu

- no -

direccion@hpss.ssp.sld.cu

- no -

docencia@ali.cav.sld.cu

hegdir@ltu.sld.cu

hcsm@grannet.grm.sld.cu

hcmc@grm.sld.cu

- no -

docencia@hospclin.scu.sld.cu

hgd@hgdan.gtm.sld.cu

- no -

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

Study completion date:

30/09/2025

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000410

Date of Registration in Primary Registry:

22/09/2022

Record Verification Date:

2022/09/22

Next update date:

2023/09/22

Link to the spanish version:

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NeuroEPO in mild-moderate Alzheimer's disease amnesic variant

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