Effects of a Nutraceutic Compound on Cognitive Impairment (ENUCCI)

January 9, 2024 updated by: RAFFAELE IZZO, Federico II University

Effects of a Nutraceutic Compound on Cognitive Impairment in Frailty Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80131
        • Ambulatorio Ipertensione e Unità Coronarica Federico II University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Mild cognitive impairment

Exclusion Criteria:

Ictus Atrial fibrillation Kidney diseases Cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo oral tablet. In the Placebo group the participants take vehicle (1 vial per os every 24 hours) for 4 weeks
Drug: Placebo oral vial
In the Placebo group the participants take vehicle (1 vial per os every 24 hours) for 4 weeks
Active Comparator: CERBRAIN
In the CEREBRAIN group the participants take CEREBRAIN (1 vial per os of 1.2 g every 24 hours) for 4 weeks
Drug: Choline Bitartrate
In the CEREBRAIN group the participants take CEREBRAIN (1 vial per os of 1.2 g every 24 hours) for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cognitive functions
Time Frame: 4 weeks
Cognitive functions will be assessed by MoCA test
4 weeks
Change in Cognitive functions
Time Frame: 4 weeks
Cognitive functions will be assessed by MMSE test
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Estimated)

January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEREBRAIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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