Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-31 @ 11:31 AM
Study NCT ID:
NCT04920305
Status:
UNKNOWN
Last Update Posted:
2022-05-11
First Post:
2021-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phosphatidylserine Improves Cognitive Function in the Elderly
Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Organization:
Study Overview
Official Title:
Clinical Study on the Effect of Phosphatidylserine on Cognitive Function Improvement in the Elderly
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
NOT_YET_RECRUITING
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:
PICFITE
Brief Summary:
Cognitive decline is a common symptom of aging, and age-related cognitive impairments are considered normal or inevitable, especially in people over 60, whose memory is more likely to be affected by age. As life expectancy has increased, the number of people with age-related cognitive impairment has also increased. The improvement or slowing of cognitive impairment has received more attention. Phosphatide is a naturally occurring Phosphatide, but it is the main acidic phospholipid in the brain. Phosphatidylserine (PS) is a phospholipid that regulates the function of key proteins in cell membranes and can improve brain function and repair brain damage. PS is thought to enhance neuronal membrane function, which in turn enhances cognitive function. However, there are few studies on the effect of PS on human cognitive function, especially on the elderly, and the results are inconsistent. In this study, people aged 60-70 were given PS intervention for 6 months. Montreal Cognitive Assessment (MOCA) and Mini-Mental State Examination.MMSE) and head MRI are used to evaluate the cognitive function of the subjects before and after the intervention to observe the influence of PS on the cognitive function of the elderly, which is of certain significance for the accurate assessment of the cognitive function of the elderly population and the improvement of the cognitive function of the elderly.
Detailed Description:
This is a randomized, controlled, double-blind clinical trial, in which 100 subjects were randomly assigned to the treatment group and the control group 1:1 by computer generated random numbers. Before start of the study, all the subjects underwent the first magnetic resonance (MR) and electroencephalogram (EEG) data collection. The working memory capacity of subjects in the N-back paradigm was measured (collected during the N-back task in the EEG test), and the cognition was measured by MOCA and MMSE. After the first data collection was completed, subjects in the treatment group oral the PS (600mg/d, q.d.) for 6 months. Subjects in the control group were given a placebo, which was the same shape of bean powder(600mg/d, q.d.). Under the supervision of nurses, all subjects took the additive at regular times daily. At the end of the 6-month additive trial, all subjects underwent a second MR and EEG data acquisition, as well as measurements of working memory capacity and cognition.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: