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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alzheimer's Disease Group | Description: Individuals diagnosed with Alzheimer's disease. Inclusion Criteria: Participants meeting established criteria for Alzheimer's disease diagnosis, which may include cognitive and memory deficits along with functional impairment. Exclusion Criteria: Exclusion of participants with significant comorbidities that could affect cognitive function and those with other forms of dementia. |
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| Amnestic Mild Cognitive Impairment (aMCI) Group | Description: Individuals diagnosed with amnestic mild cognitive impairment. Inclusion Criteria: Participants displaying cognitive decline beyond what is expected for their age but not meeting criteria for a diagnosis of Alzheimer's disease. Exclusion Criteria: Exclusion of participants with other neurological conditions that might mimic or contribute to cognitive impairment. |
| |
| Control Group (Healthy Controls) | Description: Individuals without cognitive impairment or neurological disorders. Inclusion Criteria: Participants with normal cognitive function for their age, absence of memory complaints, and no history of neurological or psychiatric disorders. Exclusion Criteria: Exclusion of individuals with any cognitive impairment, psychiatric disorders, or significant medical conditions affecting cognition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| White Matter Hyperintensity burden | 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Spatial distribution pattern | 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). | 24 months |
| TRACE4AD classifier |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with amnestic Mild Cognitive Impairment (aMCI):
These individuals have been clinically diagnosed with aMCI, a condition characterized by noticeable memory impairment beyond what is expected for age but not meeting the criteria for a diagnosis of Alzheimer's Disease.
Patients with Alzheimer's Disease (AD):
Participants diagnosed with Alzheimer's Disease based on clinical assessments.
Healthy Control Subjects:
Age-matched and gender-matched individuals without cognitive impairment or significant neurological disorders.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico San Donato | Recruiting | San Donato Milanese | Milano | 20097 | Italy |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
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. |
| 24 months |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |