IRCCS Policlinico San Donato
San Donato Milanese, Milano, 20097, Italy
Location status: Recruiting
Location contact
Francesco Sardanelli
CONTACT
Francesco Sardanelli, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06179680
This study focuses on assessing and measuring white matter hyperintensities in individuals with amnestic mild cognitive impairment (aMCI) or Alzheimer's disease.
Objective:
The primary objective of the study is to quantify the extent and distribution of white matter hyperintensities in the brains of individuals diagnosed with amnestic mild cognitive impairment or Alzheimer's disease. White matter hyperintensities are areas of increased signal intensity observed on brain magnetic resonance imaging (MRI) scans, often associated with various cognitive disorders.
Importance:
Understanding the presence and severity of white matter hyperintensities in individuals with aMCI or Alzheimer's disease is crucial for several reasons. These abnormalities may serve as potential biomarkers, aiding in the early diagnosis and prognosis of cognitive disorders. Additionally, quantifying white matter hyperintensities could contribute to a better comprehension of the underlying neuropathological processes associated with these conditions.
Methods:
The study employs advanced imaging techniques, likely including MRI, to capture and analyze white matter hyperintensities in the brains of participants with amnestic mild cognitive impairment or Alzheimer's disease. The quantification process involves precise measurement and mapping of these hyperintense regions.
Participants:
The study involves individuals diagnosed with amnestic mild cognitive impairment or Alzheimer's disease. Participants will undergo neurological assessments and imaging procedures to facilitate the accurate measurement of white matter hyperintensities.
Expected outcomes:
Researchers anticipate that the quantification of white matter hyperintensities will provide valuable insights into the progression of cognitive disorders. The results may contribute to the development of more targeted and effective diagnostic and therapeutic interventions for individuals with amnestic mild cognitive impairment or Alzheimer's disease.
Conclusion:
This study represents a significant step toward enhancing our understanding of the neuropathological changes associated with amnestic mild cognitive impairment and Alzheimer's disease. By focusing on the quantification of white matter hyperintensities, researchers aim to uncover potential markers for early detection and monitoring of these cognitive disorders.
Interested in participating?
Request Info65 year and older
All sexes
Observational
San Donato Milanese, Milano, 20097, Italy
Location status: Recruiting
Francesco Sardanelli
CONTACT
Francesco Sardanelli, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MRI Protocol: Uses advanced MRI sequences to examine brain structures and detect white matter issues.
WMH Assessment: Evaluates white matter health using various methods, including manual and automated tools.
Neuropsychological Testing: Subjects undergo comprehensive cognitive testing administered by IRCCS Policlinico San Donato's Clinical Psychology Service.
Follow-up: Patients are monitored for cognitive changes semiannually, with additional assessments for those showing signs of progression. After two years, all patients undergo examination and tests to assess their condition.
Time frame: 24 months
The primary objective is to study the difference in terms of White Matter Hyperintensity (WMH) burden normalized for intracranial volume (primary outcome) between patients with Alzheimer's Disease (AD) and control subjects. This forms the basis for calculating the sample size for prospective recruitment.
Time frame: 24 months
Evaluate the potential relationship between the extent of WMH burden, both total and specifically their spatial distribution pattern, and the risk of progression to AD dementia in patients with amnestic Mild Cognitive Impairment (aMCI).
Time frame: 24 months
Assess whether the WMH burden, in conjunction with voxel-based and volumetric analysis of gray matter and neuropsychological test results, can contribute to predicting the progression of aMCI to AD, as defined by the TRACE4AD classifier.
IRCCS Policlinico S. Donato
Other
Quantification of White Matter Hyperintensities in Subjects With Amnestic Mild Cognitive Impairment or Alzheimer's Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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