Effects of a Nutraceutic Compound on Cognitive Impairment

Phase 4

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Drug: Placebo oral vial; Drug: Choline Bitartrate

• Registration Number: NCT06200883
• Lead Sponsor: Federico II University

Brief Summary

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.

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 Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-11-01
• Study First Submitted: 2023-12-21
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Mild cognitive impairment

Exclusion Criteria

Ictus Atrial fibrillation Kidney diseases Cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral vial	Placebo oral tablet. In the Placebo group the participants take vehicle (1 vial per os every 24 hours) for 4 weeks
CERBRAIN	Choline Bitartrate	In the CEREBRAIN group the participants take CEREBRAIN (1 vial per os of 1.2 g every 24 hours) for 4 weeks

Primary Outcome Measures

Name	Time	Method
Change in Cognitive functions	4 weeks	Cognitive functions will be assessed by MMSE test

Secondary Outcome Measures

Name	Time	Method
Change in cognitive frailty	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)

Trial Locations

Locations (1)

Ambulatorio Ipertensione e Unità Coronarica Federico II University; 🇮🇹 Napoli, Italy