NeuroEPO in patients with Mild-Moderate Alzheimer's disease

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.

Acronym of Public Title:

ATHENEA

Scientific title:

Assessing The Effectiveness and safety of Nasal NeuroEpo management in patients with Alzheimer's mild/moderate

Acronym of Scientific Title:

ATHENEA

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)

Authorization date :

16/06/2017

Reference number:

170

Principal investigator

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

First name:

Jorge

Midle name:

Jesus

Last name:

Llibre Guerra

Medical Specialty :

First degree specialist in Neurology

Affiliation:

National Institute of Neurology and Neurosurgery

Postal address:

Calle D y 29. Vedado

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78383033

Email address:

jorge.llibre@gmx.com [1]

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:

Artemisa, Ivan Portuondo teaching general hospital-Provincial Comprehensive Care Community Service to Memory Disorders (SPAICTM), Saily Sosa Pérez, MD, MSc., Second degree specialist in General medicine.

Havana, Center of Isotopes-Clinical Investigations Directions, Yamile Penna Quian, MD. PhD, Second degree specialist in Nuclear medicine.

Havana, National Toxicology Center. (CENATOX). Alina Diaz Machado, MD. MSc, First degree specialist in Pharmacology

Havana, Neurosciences (CNEURO). Ana Fernández Nin, 2tho degreee neurophysiology

Research ethics committees:

National Institute of Neurology and Neurosurgery, January 5th, 2017

Hospital Ivan Portuondo, September 13th, 2016

Center of Isotopes-Clinical Investigations Directions, December 15th, 2016

National Toxicology Center (CENATOX), February 27, 2017

Neurosciences (CNEURO), in review

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

11/12/2017

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 to moderate Alzheimer's

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):

Group A (experimental): 0.5 mg NeuroEPO by intranasal route, 3 times a week for 4 weeks (induction period) and, then continuing with 1mg weekly for 44 weeks (maintenance period). Group B (experimental): 1.0 mg NeuroEPO by intranasal route, 3 times a week for 4 weeks (induction period) and then, continuing with the same doses weekly for 44 weeks (maintenance period). Group C (control): Placebo. This group will be divide in two equal subgroups (one for each experimental group). The patients will receive the same doses, schema and administration route.

Intervention code:

Erythropoietin

Neuroprotective Agents

Administration, Intranasal

Placebos

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):

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

Key secondary outcomes:

Related to efficacy: CIBIC plus (CIBIC plus scale). Measuring time: at 0, 6 and 12 months. Validity index in the basic activities of daily life (Measured by Index of Katz and Barthel). Measuring time: at 0, 6 and 12 months. Index of validity in the instrumental activities of daily life (Measured by Lawton Index). Measuring time: at 0, 6 and 12 months. Psychometric performance (Measured by Neuropsychiatric Inventory (NPI)). Measuring time: at 0, 6 and 12 months. Functional neuroimaging (by SPECT). Measuring time: at 0, 6 and 12 months. Event-related evoked potentials for P-300, N-400. Measuring time: at 0, 6 and 12 months. Mental flexibility (Measured by Trail Making, (Stroke Test)). Measuring time: at 0, 6 and 12 months. Working Memory (Measured by Trail Making). Measuring time: at 0, 6 and 12 months. Motor response rate (Measured by Trail Making). Measuring time: at 0, 6 and 12 months. Working memory (Measured by Digito spam). Measuring time: at 0, 6 and 12 months. Sustained attention (Measured by Digito spam). Measuring time: at 0, 6 and 12 months. Visuoconstructive function (Measured by Copia King figure and late evocation). Measuring time: at 0, 6 and 12 months. Visual memory (Measured by Copia King figure and late evocation). Measuring time: at 0, 6 and 12 months. Verbal fluency (Measured by Verbal Fluency Test (FAS)). Measuring time: at 0, 6 and 12 months. Degree of dementia (Measured by the GDS). Measuring time: at 0, 6 and 12 months. Related to safety: Blood pressure (mm/Hg). Measuring time: in each evaluation at 2, 6 and 12 months and in each administration of the product. Adverse Events-AE (Severity of AE (serious or not), Type of AE (accordint to Regulation 45/2007 CECMED), Intensity of AE (mild, moderate, serious), Causality relationship (Very likely, likely, possible, unlikely, unrelated or non-evaluable), Attitude about the drug (No change, dose reduction, temporary interruption of treatment, definitive discontinuation of treatment), Outcome (Reversible effect, irreversible effect, death, loss of patient follow-up)). Measuring time: in each evaluation at 2, 6 and 12 months and in each administration of the product. Laboratory test (Hemoglobin (Normal, abnormal), Hematocrit (Normal, abnormal), Platelet count (Normal, abnormal), Leukocyte count (Normal, abnormal), Glycemia (Normal, abnormal), TGO (Normal, abnormal), TGP (Normal, abnormal), GGT (Normal, abnormal), Creatinine, (Normal, abnormal), LDH (Normal, abnormal)). Measuring time: 0, 6 and 12 months.

Selection criterias

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

Gender:

Male/Female

Minimum age:

50 years

Maximum age:

None

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.

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:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2-3

Target sample size:

114

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:

Bachelor in Pharmaceutical Sciences

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216, esquina 15. Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72143202

Email :

leslie@cim.sld.cu [2]

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:

Jorge

Middle Name:

Jesus

Last Name:

Llibre Guerra

Specialty:

First degree specialist in Neurology

Affiliation:

National Institute of Neurology and Neurosurgery (INN)

Postal Address:

Calle D y 29. Vedado

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78383033

Email :

jorge.llibre@gmx.com [1]

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:

RPCEC00000232

Date of Registration in Primary Registry:

01/02/2017

Record Verification Date:

2018/06/11

Next update date:

2019/06/11

Link to the spanish version:

Click here [3]