Clinical trial NCT06179680: White Matter Hyperintensities in Amnestic Mild Cognitive Impairment or Alzheimer's Disease
Official title: Quantification of White Matter Hyperintensities in Subjects With Amnestic Mild Cognitive Impairment or Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 142
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: White Matter Hyperintensity burden
timeFrame: 24 months
Secondary outcomes:
measure: Spatial distribution pattern
timeFrame: 24 months
measure: TRACE4AD classifier
timeFrame: 24 months
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milano
Study officials:
References: