Cognitive Changes in Mild Cognitive Impairment

Recruiting

• Conditions: Healthy Controls Without Orthostatic Hypotension
• Interventions: Other: observational study

• Registration Number: NCT05821400
• Lead Sponsor: Fujian Medical University Union Hospital

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-29
• Study Start: 2023-03-01
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-06
• Last Update Submitted: 2023-04-06
• Study First Posted: 2023-04-20
• Last Update Posted: 2023-04-20
• Primary Completion: 2024-04-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Clinically diagnosed mild cognitive impairment

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls without orthostatic hypotension	observational study	-

Primary Outcome Measures

Name	Time	Method
Changes in Montreal Cognitive Assessment (MoCA) scores after 3 months.	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

Secondary Outcome Measures

Name	Time	Method
Changes in Blood pressure (mmHg) after 3 months.	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.
Changes in Plasma tau levels after 3 months.	Participants will be followed up for 3 months after baseline.	Plasma tau(ug/ml) is an important indicator of cognitive function
Changes in Plasma amyloid protein levels after 3 months.	Participants will be followed up for 3 months after baseline.	Plasma amyloid protein(ug/ml) is an important indicator of cognitive function.

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China