Policosanol on cognitive impairment after ischemic stroke

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 effects of Policosanol on cognitive impairment after ischemic stroke.

Secondary indentifying numbers:

Poli/P-DC-02

Issuing authority of the secondary identifying numbers:

National Centre for Scientific Research (CNIC)

Source(s) of monetary or material support:

National Centre for Scientific Research, Central count BioCubafarma

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:

Only approved by Ethics Committees

Principal investigator

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

First name:

Javier

Midle name:

Vicente

Last name:

Sanchez Lopez

Medical Specialty :

Second Degree Specialist in Neurology and Intensive Care

Affiliation:

Institute of Neurology and Neurosurgery (INN)

Postal address:

Calle 29 No. 139 esquina D, Plaza de la Revolucion

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-53256655

Email address:

javier.sanchez@infomed.sld.cu [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:

Not applicable

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

01/06/2026

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:

Ischemic stroke

Health condition(s) code:

Stroke

Cerebrovascular disorders

Brain diseases

Central Nervous System Diseases

Nervous System Diseases

Vascular diseases

Cardiovascular diseases

Health condition keyword:

Ischemic stroke

Intervention(s):

Group 1 Policosanol (Experimental): A tablet of Policosanol (20 mg/day) and a tablet of Aspirin (81 mg/day) by oral way, one a day taken with breakfast for 6 months. Group 2 Placebo (Control): A tablet of Policosanol Placebo (20 mg/day) and a tablet of Aspirin (81 mg/day) by oral way, one a day taken with breakfast for 6 months..

Intervention code:

Hypolipidemic Agents

Aspirin

Placebos

Tablets

Administración, Oral

Intervention keyword:

Policosanol

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):

Cognitive assessment (Montreal Cognitive Scale-MoCA). Measurement time: At baseline, 1.5, 3 and 6 months of treatment.

Key secondary outcomes:

1. Neurological assessment (It will be measured using the Rankin Scale). Measurement time: At baseline, 1.5, 3 and 6 months of treatment. 2. Neurological assessment (It will be measured using the Barthel Index score). Measurement time: At baseline, 1.5, 3 and 6 months of treatment. 3. Lipidic perfil (Values of LDL-C, TC and, HDL-C). Measurement time: At baseline, 1.5, 3 and 6 months of treatment. 4. Blood pressure (Values of Systolic blood pressure and, Diastolic blood pressure). Measurement time: At baseline, 1.5, 3 and 6 months of treatment.

Selection criterias

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

Gender:

Male/Female

Minimum age:

40 years

Maximum age:

90 years

Inclusion criteria:

Patients of both sexes, ≥ 40 years old and documented history of previous ischemic stroke or ATI with positive brain imaging-CT (diagnosed within 30 days of its onset) occurring in the previous two months, who agree to participate in the study by signing their informed consent, from the population attended in Neurology Consultations of the INN. Patients will be included who meet the recruitment criteria, with Rankin Scale scores ≥2 and ≤4 (2-4), with a Montreal Cognitive Scale (MoCA) score of 20-25, which suggests early cognitive impairment, and who do not reveal any exclusion criteria during the general interview.

Exclusion criteria:

1- Normal cognition (MoCA score equal or more than 26). 2- Established dementia. 3- Individuals who do not have conditions that: impair the function of the sensory organs (vision and hearing), cause drowsiness, stupor, confusion, delirium, severe depression, severe intellectual disability, schizophrenia, or who are bedridden. 4- History of hemorrhagic stroke or subarachnoid hemorrhage. 5- Diagnosed neoplasms. 6- Any other special condition that, in the physician's judgment, may put their health and life at risk during the study.

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:

Target sample size:

100

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:

Javier

Middle Name:

Vicente

Last Name:

Sanchez Lopez

Specialty:

Second Degree Specialist in Neurology and Intensive Care

Affiliation:

Institute of Neurology and Neurosurgery (INN)

Postal Address:

Calle 29 No. 139 esquina D, Plaza de la Revolucion

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-53256655

Email :

javier.sanchez@infomed.sld.cu [1]

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:

Julio

Middle Name:

Cesar

Last Name:

Fernandez Travieso

Specialty:

Pharmaceutical Sciences Doctor

Affiliation:

Clinical Trials Unit, National Centre for Scientific Research (CNIC)

Postal Address:

25 Avenue and 158, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-59958136

Email :

julio.fernandez@cnic.cu [2]

Research Ethics Committees

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

Name of Research Ethics Committees:

Institute of Neurology and Neurosurgery (INN)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

10/04/2026

Postal address of Ethic Committee :

Calle 29 No. 139 esquina D, Vedado, Plaza de la Revolucion, ZC: 10400, Havana. Cuba

Telephone:

+53-58238788

Correo electrónico:

zurinarabi@gmail.com

About study completion

Section to complete the data related to the study completion.

Study completion date:

01/03/2027

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:

RPCEC00000475

Date of Registration in Primary Registry:

05/05/2026

Record Verification Date:

2026/05/05

Next update date:

2027/05/05

Link to the spanish version:

Click here [3]