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OpenTrials
Completed

NCT Number: NCT06200883

Effects of a Nutraceutic Compound on Cognitive Impairment

The study is designed to evaluate the effects of choline bitartrate on cognitive impairment in frailty patients.

The study will analyze the impact of 4 weeks treatment randomized with a nutraceutical compound in a double-blind randomized placebo controlled trial. The investigators will also assess cognitive frailty.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ambulatorio Ipertensione e Unità Coronarica Federico II University

Naples, 80131, Italy

About this study

The patients and controls will be recruited at the Hypertension research center of Federico II university hospital.

The overall duration of the study will be 4 weeks for each participant. Blood pressure, heart rate and cognitive frailty and cognitive impairment will be evaluated for each patient at randomization and after 4 weeks of treatment.

Patients or controls will be randomized to receive the nutraceutical compound (1 vial of CEREBRAIN per os with 1200 mg of choline bitartrate every 24 hours) or placebo (1 vial per os without active substance every 24 hours). Before the start of treatment, patients will undergo full examination of cognitive functions (MoCA and MMSE tests, the parameters will be reported in a password-protected database, using a identification code. The duration of the treatment will be 4 weeks. At the end of the treatment, the patients will repeat the tests and the results will be identified through the use of an alphanumeric code (POST-XXXYYY).

All CEREBRAIN and placebo, made up of the CEREBRAIN vehicle without the active substance, will be offered free of charge by the Farmaceutici DAMOR company.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mild cognitive impairment

Exclusion criteria

Ictus Atrial fibrillation Kidney diseases Cancer

Treatment and study plan

Placebo oral vial

Drug

In the Placebo group the participants take vehicle (1 vial per os every 24 hours) for 4 weeks

choline bitartrate

Drug

In the CEREBRAIN group the participants take CEREBRAIN (1 vial per os of 1.2 g every 24 hours) for 4 weeks

Primary outcomes

  1. Change in Cognitive functions

    Time frame: 4 weeks

    Cognitive functions will be assessed by MoCA test

  2. Change in Cognitive functions

    Time frame: 4 weeks

    Cognitive functions will be assessed by MMSE test

Secondary outcomes

  1. Change in cognitive frailty

    Time frame: 4 weeks

    Cognitive frailty will be assessed by the Fried criteria (at least 3/5 criteria whether MCI is diagnosed with the Clinical Dementia Rating Scale (0 to 5)

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Effects of a Nutraceutic Compound on Cognitive Impairment in Frailty Patients

Acronym: ENUCCI

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 11, 2024
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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