- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05639140
A Registered Cohort Study on Color Discrimination Deficit Associated With Neurodegenerative Disorders.
November 28, 2022 updated by: Fujian Medical University Union Hospital
A Registered Observational Cohort Study on Color Discrimination Deficit Associated With Neurodegenerative Disorders.
Color discrimination deficit is a common manifestation of Alzheimer's disease (AD).
However, the pathophysiology of this dysfunction remains poorly understood.
The aim of the present study was to evaluate color discrimination using the Farnsworth-Munsell 100 hue test in patients with AD and mild cognitive impairment (MCI), compared with age-matched control subjects.
As a secondary aim, we evaluated whether the outcomes of these visual tests were associated with cognitive.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
500
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
- Name: Xiaodong Pan, Doctor
- Phone Number: 0591-86218341
- Email: pxd77316@163.com
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350000
- Recruiting
- Fujian Medical University Union Hospital
-
Contact:
- Xiaodong Pan
- Phone Number: 86218341
- Email: xieheyb@163.com
-
-
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
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The patients include who suffer from Neurodegenerative Disorders whether Color discrimination deficit or not.
Description
Inclusion Criteria:
- All patients underwent extensive clinical examination including thorough neurological and somatic examination by a specialized neurologist or geriatrician and extensive neuropsychological examination by a trained psychologist. AD was diagnosed according to the NINCDS-ADRDA criteria.
Exclusion Criteria:
- We excluded individuals with noncompensated somatic illnesses, a history of a psychiatric disorder, color blindness, ophthalmological pathology, severe cranial trauma, focal neurological signs or magnetic resonance imaging examinations suggestive of cerebrovascular disturbances.
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Color discrimination deficit
|
Neuropsychological assessment, FM-1OO, brain MRI, electroencephalogram and biomarker datas will be collected
|
Without Color discrimination deficit
|
Neuropsychological assessment, FM-1OO, brain MRI, electroencephalogram and biomarker datas will be collected
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MoCA scores
Time Frame: Baseline
|
The Montreal Cognitive Assessment (MoCA)
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ACE-III scores
Time Frame: Baseline
|
Addenbrooke's Cognitive Examination (ACE) score
|
Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TES
Time Frame: Baseline
|
The total error score
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 1, 2018
Primary Completion (Anticipated)
July 1, 2025
Study Completion (Anticipated)
July 1, 2025
Study Registration Dates
First Submitted
November 28, 2022
First Submitted That Met QC Criteria
November 28, 2022
First Posted (Estimate)
December 6, 2022
Study Record Updates
Last Update Posted (Estimate)
December 6, 2022
Last Update Submitted That Met QC Criteria
November 28, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cohort-Visual
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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