Mild Cognitive ImpairmentNCT06179680
White Matter Hyperintensities in Amnestic Mild Cognitive Impairment or Alzheimer's Disease
An observational study of Mild Cognitive Impairment and Alzheimer Disease, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 142 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jul 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, Milano, 20097
Francesco Sardanelli, 0252774468, francesco.sardanelli@grupposandonato.it
Francesco Sardanelli, MD
About this study
Official title: Quantification of White Matter Hyperintensities in Subjects With Amnestic Mild Cognitive Impairment or Alzheimer's Disease
This study focuses on assessing and measuring white matter hyperintensities in individuals with amnestic mild cognitive impairment (aMCI) or Alzheimer's disease.
Objective:
Read more
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.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Being tested
- Magnetic Resonance Imaging
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Magnetic Resonance Imaging | |
| 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. Receives: Diagnostic Test: Magnetic Resonance Imaging | |
| 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. Receives: Diagnostic Test: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (2)
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).
Measured: 24 months
TRACE4AD classifier
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start21 Jul 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Sardanelli, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179680
- Sponsor's protocol ID
- WMH-AD
- Status last verified
- Jul 2025
- First submitted
- 23 Nov 2023
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of White Matter Hyperintensities in Subjects With Amnestic Mild Cognitive Impairment or Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06179680
- Acronym / sponsor ID
- WMH-AD
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease Group | – | Diagnostic Test: Magnetic Resonance ImagingDescription: 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. |
| Amnestic Mild Cognitive Impairment (aMCI) Group | – | Diagnostic Test: Magnetic Resonance ImagingDescription: 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) | – | Diagnostic Test: Magnetic Resonance ImagingDescription: 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingMRI 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. | Diagnostic test | Alzheimer's Disease Group, Amnestic Mild Cognitive Impairment (aMCI) Group, Control Group (Healthy Controls) |
Primary outcome
White Matter Hyperintensity burden
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.
2 secondary outcomes
Spatial distribution pattern
Time frame: 24 months
TRACE4AD classifier
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
IRCCS Policlinico San Donato
San Donato Milanese, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Alzheimer Disease, run by IRCCS Policlinico S. Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
White Matter Hyperintensity burden (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.