Quality of Life and safety of the nutritional supplement Deprexil® or Placebo in combination with cognitive stimulation treatment in patients with Mild Cognitive Impairment and Mild Alzheimer's Dementia.

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:

Exploratory, monocentric, placebo-controlled, randomized, double-blind clinical trial to evaluate the Quality of Life and safety of the nutritional supplement Deprexil® in combination with cognitive stimulation treatment in patients with Mild Cognitive Impairment and Mild Alzheimer's Dementia.

Secondary indentifying numbers:

CAT-2021-1

Issuing authority of the secondary identifying numbers:

National Coordinating Center for Clinical Trials

Source(s) of monetary or material support:

Catalysis Laboratories, SL

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:

Trials notification

Regulatory instance:

National Institute of Hygiene, Epidemiology and Microbiology (INHEM)

Notification date :

13/02/2024

Reference number:

In process

Principal investigator

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

First name:

Yadira

Last name:

Hernandez Pino

Medical Specialty :

First Degree Specialist in Geriatrics and Gerontology/First Degree Specialist in Comprehensive General Medicine

Affiliation:

"Hermanos Ameijeiras" Clinical Surgical Hospital

Postal address:

San Lazaro # 701 esq. to Belascoain. Centro Habana

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78765178

Email address:

yadirahdz@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:

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:

20/03/2024

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 Cognitive Impairment and Mild Alzheimer's Dementia

Intervention(s):

Patients with Mild Cognitive Impairment Deprexil Group (Experimental): Deprexil + Cognitive stimulation. Deprexil will be administered one vial (30 ml) Deprexil® oral solution every 12 hours (given after breakfast and lunch) for 6 months Placebo Group (Control): Placebo + Cognitive stimulation. The placebo will be administered in the same way and with the same frequency and duration as Deprexil. Patients with Mild Alzheimer's Dementia Deprexil Group (Experimental): Deprexil + Cognitive stimulation. Deprexil will be administered one vial (30 ml) Deprexil® oral solution every 12 hours (given after breakfast and lunch) for 6 months. In addition, they can receive pharmacological treatment if required. Placebo Group (Control): Placebo + Cognitive stimulation. The placebo will be administered in the same way and with the same frequency and duration as Deprexil. In addition, they can receive pharmacological treatment if required.

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):

Quality of Life (SF-36 health questionnaire. The questionnaire has 36 items distributed in 8 dimensions: physical function (10 items), physical role (4 items), body pain (2 items), general health (5 items), vitality (4 items), social function (2 items), emotional role (3 items) and mental health (5 items); item 2 is related to health transition. Each item is expressed on a scale from 0 to 100 with a point cut-off at 50, above and below which there are positive or negative health states. The change in final value with respect to the baseline value will be measured in the scores of the domains and summary scores of the questionnaire. The following categories will be established: poor Quality of Life if the total score is from 0 to 25, regular Quality of Life from 26 to 50, good Quality of Life from 51 to 75 and excellent Quality of life from 76 to 100 points). Measurement time: At baseline, month 3 and one week after the end of treatment.

Key secondary outcomes:

1. Functional capacity (It will be evaluated using the Lawton and Brody scale where 0 to 1 point is considered Total dependence, Severe dependence from 2 to 3 points, Moderate dependence from 4 to 5 points, Light dependence from 6 to 7 points, and Independence 8 points.). Measurement time: At baseline, month 3 and, a week after the end of treatment. 2. Cognitive Status (It will be evaluated using the Folstein Mini Mental State Examination (MMSE), the Reisberg Global Impairment Scale (GDS) and the Montreal Cognitive Assessment (MoCA) Test. The MMSE gives a score where from 24 to 30 points is evaluated as “no cognitive deficit”, between 18 and 23 points as “Slight cognitive deficit” and 17 points or less as “Severe cognitive deficit”. The GDS gives a score that ranges from 1 (absence of cognitive deficit) to 7 (very severe cognitive deficit) and the MoCA that gives a maximum score of 30 points, where a score equal to or greater than 26 points is considered normal (no alteration of cognitive functions) and less than 26 indicates alteration of cognitive functions). Measurement time: At baseline, month 3 and, a week after the end of treatment. 3. Brain metabolism (It will be evaluated through a neuroimaging study, Positron Emission Tomography (PET). The limbic structures (hippocampal complex, medial thalamus, mammillary body, and the posterior cingulate; or temporo-parietal region) and the structure will be studied. A favorable response will be considered if an increase in metabolism is observed when there are 2 or more standard deviations above the controls provided by the equipment as an average according to the areas studied in the final evaluation with respect to the baseline result, and unfavorable if contrary). Measurement time: At baseline and, a week after the end 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:

60 years

Maximum age:

None

Inclusion criteria:

1. Patients aged ≥ 60 years. 2. Time of evolution of the disease less than 2 years. 3. Patients who have the results of laboratory tests, imaging tests (CT), as well as neurocognitive and functional tests. 4. Patients and/or reliable informant who grant their consent to participate in the study by signing the informed consent model. Inclusion Criteria for MCI 1.Patients who meet the diagnostic criteria for MCI according to the International Working Group on Mild Cognitive Impairment. Inclusion Criteria for Mild Alzheimer's Dementia 1. Patients who meet the diagnostic criteria for mild Alzheimer's dementia according to DSM-IV.

Exclusion criteria:

1. Patients with severe loss of vision, hearing or communication skills. 2. Patients with the presence of an active systemic disease (e.g., cancer, rheumatoid arthritis, lupus erythematosus, etc.) or another chronic neurological disease (e.g., Parkinson's disease, multiple sclerosis) or psychiatric disease (e.g. major depression, schizophrenia, mental retardation, bipolar disorder). 3. Patients with infectious diseases of the Central Nervous System. 4. Patients with a history of craniocerebral trauma. 5. Patients with a history of known cerebrovascular disease or brain tumor, or diagnosed by CT, at the time of inclusion. 6. Patients at risk of frequent bleeding or taking medications that thin the blood (warfarin). 7. Patients addicted to alcohol or drugs, or treated with psychotropic drugs at the time of inclusion. 8. Patients with elevated thyroid hormone levels with clinical significance. 9. Patients who are participating in another clinical trial. 10. Patients with a known allergy to any ingredient of the supplement or placebo. Note: In patients receiving vitamin or nutritional supplements (vitamin C, vitamin B12, folic acid, vitamin B6, ginkgo biloba), it should be taken as a concomitant treatment and the doses to be ingested should be controlled at the doctor's discretion.

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:

N/A

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:

Keyla

Middle Name:

de la Caridad

Last Name:

Martinez Herve

Specialty:

Bachelor degree in Pharmaceutical Sciences. Clinical Research Assistant

Affiliation:

National Coordinating Center for Clinical Trials

Postal Address:

Calle 5ta A e/ 60 y 62, Miramar, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72164220

Email :

keyla@cencec.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:

Ivis

Middle Name:

Cristina

Last Name:

Mendoza Hernandez

Specialty:

Bachelor degree in Pharmaceutical Sciences. Master in Pharmacology and, Master in Clinical Trials

Affiliation:

National Coordinating Center for Clinical Trials

Postal Address:

Calle 5ta A e/ 60 y 6, Miramar, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72164227

Email :

ivis@cencec.sld.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

"Hermanos Ameijeiras" Clinical Surgical Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

20/01/2024

Postal address of Ethic Committee :

Calle San Lazaro # 701 esq. a Belascoain, Centro Habana, Havana, Z.C:10400, Cuba

Telephone:

+53-78761210

Correo electrónico:

alvaca@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

05/04/2025

Date of available results:

31/12/2025

Date of first publication:

31/12/2026

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:

RPCEC00000435

Date of Registration in Primary Registry:

07/03/2024

Record Verification Date:

2024/03/07

Next update date:

2025/03/07

Link to the spanish version:

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Quality of Life and safety of the nutritional supplement Deprexil® or Placebo in combination with cognitive stimulation treatment in patients with Mild Cognitive Impairment and Mild Alzheimer's Dementia.

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