Cognitive Changes in Mild Cognitive Impairment

April 6, 2023 updated by: Fujian Medical University Union Hospital

Cognitive Changes in Mild Cognitive Impairment Without Orthostatic Hypotension

Background: In recent years, the changes of cognitive function in mild cognitive impairment have attracted attention.

Methods/design: We will follow up at 3. The primary outcome will be the measurement of cognitive function using neuropsychological assessment scales such as MOCA, MMSE, etc... Minor variables will be included plasma biomarkers (Aβ, Tau, GFAP, etc.), multimodal brain electrophysiology (P300, VP300, heart rate variability, etc.), and neuroimaging indicators (NODDI).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Chinese who met the inclusion and exclusion criteria

Description

Inclusion Criteria:

  • Clinically diagnosed mild cognitive impairment

Exclusion Criteria:

  • Patients with orthostatic hypotension
  • Patients with other neurological disorders.
  • Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy controls without orthostatic hypotension
Other: observational study
observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Montreal Cognitive Assessment (MoCA) scores after 3 months.
Time Frame: Participants will be followed up for 3 months after baseline.
The MOCA scale scores range from 0 to 30, with higher scores indicating better cognition
Participants will be followed up for 3 months after baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Plasma tau levels after 3 months.
Time Frame: Participants will be followed up for 3 months after baseline.
Plasma tau(ug/ml) is an important indicator of cognitive function
Participants will be followed up for 3 months after baseline.
Changes in Plasma amyloid protein levels after 3 months.
Time Frame: Participants will be followed up for 3 months after baseline.
Plasma amyloid protein(ug/ml) is an important indicator of cognitive function.
Participants will be followed up for 3 months after baseline.
Changes in Blood pressure (mmHg) after 3 months.
Time Frame: Participants will be followed up for 3 months after baseline.
An experienced physician will measure blood pressure on the right upper arm after the subject rest for 5 min, taking the average of the two measurements as the final result.
Participants will be followed up for 3 months after baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University Union Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

September 29, 2022

First Submitted That Met QC Criteria

April 6, 2023

First Posted (Actual)

April 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cohort-MCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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