NCT05639140

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

December 6, 2022

Status Verified

November 1, 2022

Enrollment Period

7.5 years

First QC Date

November 28, 2022

Last Update Submit

November 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • MoCA scores

    The Montreal Cognitive Assessment (MoCA)

    Baseline

Secondary Outcomes (1)

  • ACE-III scores

    Baseline

Other Outcomes (1)

  • TES

    Baseline

Study Arms (2)

Color discrimination deficit

Other: Data collection

Without Color discrimination deficit

Other: Data collection

Interventions

Neuropsychological assessment, FM-1OO, brain MRI, electroencephalogram and biomarker datas will be collected

Color discrimination deficitWithout Color discrimination deficit

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients include who suffer from Neurodegenerative Disorders whether Color discrimination deficit or not.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

MeSH Terms

Conditions

Neurodegenerative Diseases

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Xiaodong Pan, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 6, 2022

Study Start

January 1, 2018

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

December 6, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations