Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06200883
Status:
COMPLETED
Last Update Posted:
2024-01-11
First Post:
2023-12-21
Brief Title:
Effects of a Nutraceutic Compound on Cognitive Impairment
Sponsor:
Federico II University
Organization:
Federico II University
Study Overview
Official Title:
Effects of a Nutraceutic Compound on Cognitive Impairment in Frailty Patients
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENUCCI
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None