Clinical trial NCT04920305: Phosphatidylserine Improves Cognitive Function in the Elderly
Official title: Clinical Study on the Effect of Phosphatidylserine on Cognitive Function Improvement in the Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Keywords: Aging
Phosphatide
Cognitive
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Air Force Military Medical University, China
name: Fengdong New Town Elderlywelfare Service Center
First posted: 2021-06-09
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

- Age 60 to 70, gender is not limited.

Exclusion Criteria:

* Delirium, confusion, confusion of consciousness.
* Alzheimer's disease, Parkinson's disease, stroke, cerebral hemorrhage, brain tumor, hydrocephalus.
* Viral, fungal, and syphilis infections.
* Sufferers from cerebrovascular disease (as demonstrated by a Hachinski ischemic score, or neuroimaging test).
* Repeated mild head trauma, or head trauma resulting in loss of consciousness (more than 1h).
* Depression, mania, and other mental disorders.
* Alcoholism and drug dependence.
* The following diseases may lead to mental retardation:

Kidney disease, respiratory system disease, heart disease, liver disease, uncontrolled diabetes, endocrine, metabolic, blood disease, malignant disease, more than 2 years have not been relieved.

* Taken any medication that may cause psychosis or affect intelligence in the past 1 month.
* known allergy to phosphatidylserine or related ingredients.

Primary outcomes:
measure: The change of functional connectivity, points .
timeFrame: 1 Year
Secondary outcomes:
measure: The change of point in Montreal Cognitive Assessment (MoCA) test
timeFrame: 1 Year
measure: The change of point in Mini-mental State Examination (MMSE) test, points.
timeFrame: 1 Year
measure: The change of working memory test, points.
timeFrame: 1Year.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Fengdong New City Service Center for the Elderly
state: Shaanxi
Study officials:
affiliation: The First Affiliated Hospital of Xi 'an Jiaotong University
name: Weimin Li, Dr.
role: STUDY_DIRECTOR
References: