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Clinical Trials/NCT05821400
NCT05821400
Recruiting
Not Applicable

Cognitive Changes in Mild Cognitive Impairment Without Orthostatic Hypotension

Fujian Medical University Union Hospital1 site in 1 country200 target enrollmentStarted: March 1, 2023Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
200
Locations
1
Primary Endpoint
Changes in Montreal Cognitive Assessment (MoCA) scores after 3 months.

Overview

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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
30 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Clinically diagnosed mild cognitive impairment

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Changes in Blood pressure (mmHg) after 3 months.(Participants will be followed up for 3 months after baseline.)
  • Changes in Plasma tau levels after 3 months.(Participants will be followed up for 3 months after baseline.)
  • Changes in Plasma amyloid protein levels after 3 months.(Participants will be followed up for 3 months after baseline.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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