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临床试验/NCT06200883
NCT06200883已完成4 期

Effects of a Nutraceutic Compound on Cognitive Impairment in Frailty Patients

Federico II University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年9月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
58
试验地点
1
主要终点
Change in Cognitive functions

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mild cognitive impairment

排除标准

  • Ictus Atrial fibrillation Kidney diseases Cancer

研究组 & 干预措施

Placebo

Placebo Comparator

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

干预措施: Placebo oral vial (Drug)

CERBRAIN

Active Comparator

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

干预措施: Choline Bitartrate (Drug)

结局指标

主要结局

Change in Cognitive functions

时间窗: 4 weeks

Cognitive functions will be assessed by MMSE test

次要结局

  • Change in cognitive frailty(4 weeks)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

RAFFAELE IZZO

Raffaele Izzo

Federico II University

研究点 (1)

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