CClinicalTrials.gg
Status unknownNCT05821400Updated Apr 20, 2023

Cognitive Changes in Mild Cognitive Impairment

An observational study in Healthy Controls Without Orthostatic Hypotension, sponsored by Fujian Medical University Union Hospital. Status unknown at 1 site in China. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-20.

Sponsored by Fujian Medical University Union Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
30 Years to 80 Years
Sex
All
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Study 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).

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Conditions studied

  • Healthy Controls Without Orthostatic Hypotension

Keywords

  • cognition
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In context

Hypotension, Orthostatic

155 studies on the registry are indexed under Hypotension, Orthostatic; 34 are open to participants now.

This study's planned enrollment of 200 is above the median of 50 across 34 observational studies indexed under Hypotension, Orthostatic.

Browse Hypotension, Orthostatic studies →

Lead sponsor

Fujian Medical University Union Hospital is the lead sponsor of 100 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Chinese who met the inclusion and exclusion criteria

Inclusion criteria

  • Clinically diagnosed mild cognitive impairment

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Healthy controls without orthostatic hypotension

    Other: observational study

Interventions

  • Otherobservational study

    observational study

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What researchers measure

Primary outcomes

  1. Changes in Montreal Cognitive Assessment (MoCA) scores after 3 months.

    The MOCA scale scores range from 0 to 30, with higher scores indicating better cognition

    Time frame: Participants will be followed up for 3 months after baseline.

Secondary outcomes

  1. Changes in Plasma amyloid protein levels after 3 months.

    Plasma amyloid protein(ug/ml) is an important indicator of cognitive function.

    Time frame: Participants will be followed up for 3 months after baseline.

  2. Changes in Plasma tau levels after 3 months.

    Plasma tau(ug/ml) is an important indicator of cognitive function

    Time frame: Participants will be followed up for 3 months after baseline.

  3. Changes in Blood pressure (mmHg) after 3 months.

    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.

    Time frame: Participants will be followed up for 3 months after baseline.

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Study locations

1 of 1 sites recruiting
  • Fujian Medical University Union Hospital
    Fuzhou, Fujian 350000, China
    Recruiting
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References and documents

Publications

  • Petersen RC, Roberts RO, Knopman DS, Geda YE, Cha RH, Pankratz VS, Boeve BF, Tangalos EG, Ivnik RJ, Rocca WA. Prevalence of mild cognitive impairment is higher in men. The Mayo Clinic Study of Aging. Neurology. 2010 Sep 7;75(10):889-97. doi: 10.1212/WNL.0b013e3181f11d85. PubMed 20820000 ↗
  • Rabe-Jablonska J, Bienkiewicz W. [Anxiety disorders in the fourth edition of the classification of mental disorders prepared by the American Psychiatric Association: diagnostic and statistical manual of mental disorders (DMS-IV -- options book]. Psychiatr Pol. 1994 Mar-Apr;28(2):255-68. Polish. PubMed 8208869 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05821400
Lead sponsor
Fujian Medical University Union Hospital
Responsible party
Sponsor
First posted
Apr 20, 2023
Start date
Mar 1, 2023
Primary completion
Apr 30, 2024 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Apr 20, 2023

Study contacts

Xiaodong Pan, Doctor
Contact
pxd77316@163.com
86218341

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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