NCT04920305

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

May 21, 2021

Last Update Submit

May 10, 2022

Conditions

Aging

Keywords

AgingPhosphatideCognitive

Outcome Measures

Primary Outcomes (1)

  • The change of functional connectivity, points .

    the strength of functional connectivity, from 0 to 1

    1 Year

Secondary Outcomes (3)

  • The change of point in Montreal Cognitive Assessment (MoCA) test

    1 Year

  • The change of point in Mini-mental State Examination (MMSE) test, points.

    1 Year

  • The change of working memory test, points.

    1Year.

Study Arms (2)

Phosphatidylserine group

EXPERIMENTAL

subjects in the treatment group oral the PS (600mg/d, q.d.) for 6 months.

Dietary Supplement: Phosphatidylserine

Bean powder group

PLACEBO COMPARATOR

Subjects in the control group were given a placebo, which was the same shape of bean powder(600mg/d, q.d.) for 6 months.

Dietary Supplement: Bean powder

Interventions

PhosphatidylserineDIETARY_SUPPLEMENT

subjects in the treatment group oral the PS (600mg/d, q.d.) for 6 months.

Phosphatidylserine group
Bean powderDIETARY_SUPPLEMENT

Subjects in the control group were given a placebo, which was the same shape of bean powder(600mg/d, q.d.).

Bean powder group

Eligibility Criteria

Age60 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Age 60 to 70, gender is not limited.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fengdong New City Service Center for the Elderly

Xi'an, Shaanxi, 710086, China

Location

MeSH Terms

Interventions

Phosphatidylserines

Intervention Hierarchy (Ancestors)

GlycerophospholipidsPhosphatidic AcidsGlycerophosphatesPhospholipidsMembrane LipidsLipids

Study Officials

  • Weimin Li, Dr.

    First Affiliated Hospital Xi'an Jiaotong University

    STUDY DIRECTOR

Central Study Contacts

Weimin Li, Dr.

CONTACT

0086-85323549liweimin1@xjtu.edu.cn

Xia Liao, Dr.

CONTACT

0086-85323549fraya0213@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2021

First Posted

June 9, 2021

Study Start

September 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

May 11, 2022

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)