Expanded clinical use of NeuralCIM in mild to moderate Alzheimer's disease (REAL study)

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:

REAL study

Scientific title:

Expanded clinical use of NeuralCIM for the re-treatment of patients with mild-to-moderate Alzheimer's disease following a period of treatment interruption (REAL study)

Acronym of Scientific Title:

REAL study

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Center for 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:

Calle 37 entre 72 y 74, San Antonio de los Bannos

City:

Artemisa

Country:

Cuba

Zip Code:

32500

Telephone:

+53-47383146

+53-54270955

Email address:

zailysosaz@infomed.sld.cu

sosasaily1270@gmail.com

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:

Matanzas, Faustino Perez Hospital, Leanet Martin Bernia, MD. First Degree Specialist in Neurology

Cienfuegos, Gustavo Aldereguia Lima Hospital, Julio Lopez Arguelles, MD. First Degree Specialist in Neurology

Villa Clara, Arnaldo Milian Castro Hospital, Marbelys Guevara Rodriguez, MD. First Degree Specialist in Neurology

Sancti Spiritus, Camilo Cienfuegos Hospital, Katiuska Iglesias Monagas, MD. First Degree Specialist in Neurology

Camaguey, Manuel Ascunce Domenech Hospital, Odalmis Chacon Borrero, MD. First Degree Specialist in Geriatrics and Gerontology

Ciego de Avila, Roberto Rodriguez Hospital, Luis Antonio Rodriguez Sanchez, Md. Second Degree Specialist in Internal Medicine

Ciego de Avila, Antonio Luaces Hospital, Adrian Pedroso Rios, MD. First DegreeSpecialist in MGI

Las Tunas, Ernesto Guevara Hospital, Melitza de la Caridad Pupo Machado, MD. First DegreeSpecialist in Neurology

Granma, Celia Sanchez Manduley Hospital, Eduardo Almeida Toledo, MD. First Degree Specialist in MGI

Granma, Carlos M. de Cespedes Hospital, Mabel Rosa Oduardo Aguilar, MD. First Degree Specialist in Neurology

Santiago de Cuba, Saturnino Lora Hospital, Elizabeth Colina Avila, MD. First Degree Specialist in Neurology

Santiago de Cuba, Juan Bruno Zayas Hospital, Monica Rodriguez Montalvan, MD. First Degree Specialist in Neurology

Guantanamo, Agosthino Neto Hospital, Niorvis Martin Abiague, MD. First Degree Specialist in Neurology

Holguin, Lucia Inniguez Hospital, Pedro Enrique Labrada Aguilera, MD. Second Degree Specialist in Neurology

Havana, Hermanos Ameijeiras Hospital, Nelson Gomez Viera Ph.D, MD. Second Degree Specialist in Neurology

Havana, Dr. Carlos J. Finlay Hospital, Mercedes Zamora Mayet, MD. First Degree Specialist in Neurology

Havana, International Center of Neurological Restoration, Yordanka M. Ricardo de la Fe Ph.D, MD. First Degree Specialist in Neurology

Havana, Enrique Cabrera Hospital, Roberto Hernandez Goya, MD. First Degree Specialist in Neurology

Havana, Salvador Allende Hospital, Jorge Luis Matos Ph.D, MD. First Degree Specialist in Neurology

Havana, Cristobal Labra Polyclinic, Ana Lidia Rodriguez Blanco Ph.D, MD. Second Degree Specialist in Internal Medicine and Comprehensive General Medicine

Havana, Institute of Neurology and Neurosurgery, Giosmany Bringas Sanchez, MD. Second Degree Specialist in Neurology

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

14/09/2026

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

Health condition keyword:

Intervention(s):

NeuroEPO group (Experimental): 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:

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):

Change in ADAS-Cog11 scale score from treatment restart to 12 months post-restart (0–9 points: normal; 10–15 points: mild cognitive impairment [MCI]; 16–24 points: mild stage, GDS 3 or GDS 4; 25–30 points: moderate stage, GDS 4; 31–45 points: moderate-to-severe stage, GDS 4 or GDS 5; >45 points: severe stage, GDS 6 or higher). Measurement time: At baseline and Week 52.

Key secondary outcomes:

1.- Proportion of patients with stability/improvement in ADAS-Cog11 at 24 months (0–9 points: normal; 10–15 points: mild cognitive impairment [MCI]; 16–24 points: mild stage, GDS 3 or GDS 4; 25–30 points: moderate stage, GDS 4; 31–45 points: moderate-to-severe stage, GDS 4 or GDS 5; >45 points: severe stage, GDS 6 or higher). Measurement time: Week 104. 2.- Degree of dementia (Measured by GDS, where 1 = no 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: At baseline, weeks 52, and 104. 3.- General cognitive status (Measured by MoCA, where ≥26 points: normal; 25–22 points: MCI; 21–18 points: mild impairment; 17–14 points: moderate impairment; <14 points: severe impairment). Measurement time At baseline, weeks 52, and 104. 4.- Functional status index for basic activities of daily living (Measured by the Katz Index, where: A. Independent in all functions; B. Independent in all functions except one; C. Independent in all functions except bathing and one other; D. Independent in all functions except bathing, dressing, and one other; E. Independent in all functions except bathing, dressing, toileting, and one other; F. Independent in all functions except bathing, dressing, toileting, mobility, and one other; G. Dependent in all functions; H. Dependent in at least two functions but not classifiable as C, D, E, or F). Measurement time: At baseline, weeks 52, and 104. 5.- Functional status index for instrumental activities of daily living (Measured by the Lawton Index, where: Women: 0-1 point = total dependence, 2-3 points = severe, 4-5 points = moderate, 6-7 points = mild, 8 points = independent; Men: 0 points = total dependence, 1 point = severe, 2-3 points = moderate, 4 points = mild, 5 points = independent). Measurement time: At baseline, weeks 52, and 104. 6.- Psycho-behavioral manifestations (Measured by the NPI, where the maximum score is 120 points; a higher score indicates a worse condition for the patient). Measurement time: At baseline, weeks 52, and 104. 7.- Mini-Mental State Examination (MMSE) (30–27 points: no cognitive impairment; 26–24: possible or questionable cognitive impairment; 23–17: mild cognitive impairment; 16–10: moderate cognitive impairment; <10: severe cognitive impairment). Measurement time: At baseline, weeks 52, and 104. 8.- Adverse Events (AEs) (AE severity: serious, non-serious; AE type: classified according to categories established in CECMED Regulation 45/2007; AE intensity: mild, moderate, severe; AE causality: definite, very probable, probable, possible, unlikely, unrelated, not evaluable; Action taken regarding the drug: no change, dose modification, temporary or permanent discontinuation; Outcome: recovered, recovered with sequelae requiring treatment, recovered with sequelae not requiring treatment, death; AE duration: time elapsed between AE detection and resolution; Organ and system: according to CTCAE v5.0 terminology, identifying them based on anatomical or physiological system, etiology, or purpose). Measurement time: Up to week 104. 9.- Laboratory parameters (Hemoglobin; Hematocrit, according to values stipulated at each center). Measurement time: At baseline, weeks 26, 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:

50 years

Maximum age:

None

Inclusion criteria:

1. Patients from clinical trials RPCEC00000409 and RPCEC00000410 who have completed these studies and experienced a benefit from the use of NeuralCIM. 2. Patient and caregiver who provide consent to participate in the study by signing the informed consent form. 3. Patient with a caregiver who is physically and mentally capable of understanding the study and willing to collaborate with the research. 4. Patients with patent airways.

Exclusion criteria:

1. Medical condition acquired before resuming treatment with NeuralCIM that may be contributing to a worsening of cognitive impairment in the subject (substance abuse, AIDS, syphilis, stroke or other cerebrovascular disease, head trauma, brain tumor). 2. Unstable/uncontrolled psychiatric illness prior to resuming treatment with NeuralCIM (e.g., major depression, schizophrenia, bipolar disorder). 3. History of cancer, Parkinson's disease, stage 4-5 kidney disease, moderate-to-severe liver disease, moderate-to-severe anemia before resuming treatment with NeuralCIM. 4. History of clinical disorders consistent with hypothyroidism or hyperthyroidism before resuming treatment with NeuralCIM. 5. Subjects who were receiving treatment with antipsychotics, barbiturates, monoamine oxidase inhibitors, benzodiazepines and antidepressants before resuming treatment with NeuralCIM, at doses that may compromise the proper interpretation of the scales that will be used. 6. Patients who are receiving some of the approved drugs for Alzheimer's disease (donepezil, rivastigmine, galantamine, memantine, lecanemab, donanemab) before resuming treatment with NeuralCIM. 7. 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:

N/A

Target sample size:

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:

Lidia

Last Name:

Morejon Gamboa

Specialty:

First Degree Specialist in Immunology

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216, Esquina 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72717933

Email :

lidiam@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:

Second degree specialist in Internal Medicine

Affiliation:

Ivan Portuondo Hospital

Postal Address:

Calle 37 e/ 72 y 74, San Antonio de los Bannos

City:

Artemisa

Country:

Cuba

Zip Code:

32500

Telephone:

+53-47383146

Email :

zailysosaz@infomed.sld.cu

sosasaily1270@gmail.com

Research Ethics Committees

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

Name of Research Ethics Committees:

Ivan Portuondo Hospital (centralized for the study)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

19/06/2026

Postal address of Ethic Committee :

Calle 37 entre 72 y 74, San Antonio de los Bannos. Artemisa, ZC 32500. Cuba

Telephone:

+53-47382892

Email:

ivanp@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

01/07/2030

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:

RPCEC00000484

Date of Registration in Primary Registry:

28/09/2026

Record Verification Date:

2026/09/28

Next update date:

2027/09/28

Link to the spanish version:

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Expanded clinical use of NeuralCIM in mild to moderate Alzheimer's disease (REAL study)

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