Cognitive Changes in Mild Cognitive Impairment
1 other identifier
observational
200
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2022
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedFirst Posted
Study publicly available on registry
April 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedApril 20, 2023
April 1, 2023
1.2 years
September 29, 2022
April 6, 2023
Conditions
Keywords
Outcome Measures
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
Participants will be followed up for 3 months after baseline.
Secondary Outcomes (3)
Changes in Plasma amyloid protein levels 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 Blood pressure (mmHg) after 3 months.
Participants will be followed up for 3 months after baseline.
Study Arms (1)
Healthy controls without orthostatic hypotension
Interventions
Eligibility Criteria
Chinese who met the inclusion and exclusion criteria
You may qualify if:
- Clinically diagnosed mild cognitive impairment
You may not qualify if:
- Patients with orthostatic hypotension
- Patients with other neurological disorders.
- Pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000, China
Related Publications (2)
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.
PMID: 20820000BACKGROUNDRabe-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.
PMID: 8208869BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2022
First Posted
April 20, 2023
Study Start
March 1, 2023
Primary Completion
April 30, 2024
Study Completion
June 30, 2024
Last Updated
April 20, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE