White Matter Hyperintensities in Amnestic Mild Cognitive Impairment or Alzheimer's Disease

Recruiting

• Conditions: Mild Cognitive Impairment; Alzheimer Disease

• Registration Number: NCT06179680
• Lead Sponsor: IRCCS Policlinico S. Donato

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-21
• Study First Submitted: 2023-11-23
• Study First Submitted QC: 2023-12-11
• Study First Posted: 2023-12-22
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-09
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• Participants diagnosed with amnestic Mild Cognitive Impairment (aMCI) or Alzheimer's Disease (AD) based on clinical assessments.
• Individuals undergoing brain magnetic resonance imaging (MRI) at the IRCCS Policlinico San Donato as part of routine diagnostic procedures.
• Age-matched and gender-matched healthy control subjects for comparison.

Exclusion Criteria

• Individuals with cognitive impairment other than amnestic MCI or AD.
• History of significant neurological disorders (other than MCI or AD) that may impact the study outcomes.
• Presence of contraindications for undergoing MRI procedures.
• Any serious medical or psychiatric condition that, in the judgment of the researchers, may interfere with the study participation or compromise the validity of the results.
• Known history of alcohol or substance abuse that may affect cognitive function.
• Inability or unwillingness to provide informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
White Matter Hyperintensity burden	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.

Secondary Outcome Measures

Name	Time	Method
TRACE4AD classifier	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.
Spatial distribution pattern	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).

Trial Locations

Locations (1)

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, Milano, Italy