Dementia FrontalNCT06217237
Optimization and Harmonization of Advanced MRI Sequences
An observational study of Dementia Frontal and Dementia Alzheimers, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
Development of a shared multimodal MRI protocol for the definition and quantification of imaging biomarkers in AD, DLB, FDT dementias, especially white matter alterations. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Dementia Frontal, Dementia Alzheimers, Lewy Body Variant of Alzheimer Disease
- What is being tested?
- AD FDT DBL GROUP
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2019to 10 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients and controls recruited based on the inclusion criteria carry out clinical and neuropsychological tests
Who may be able to join
- for patients
- accident cases
- time of onset of NOT MORE THAN 24 months
- Clinical Dementia Rating Scale (CDR) <=2;
- MoCA<=17
- for controls absence of complaints of cognitive disorders and/or neurological/neuropsychological visits for the evaluation of such disorders;
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- CDR = 0;
- MoCA>=27. for all Age >= 50 and <= 80;
- Hachinski Ischemic Scale - 7 items < 2;
- visual and/or auditory acuity sufficient to carry out the neuropsychological assessment;
- if on neuropsychopharmacological therapy, stability for 4 weeks before the start of the study.
Who cannot join
- for all
- any uncontrolled medical condition or neurological/neurodegenerative disease that, in the opinion of the recruiting physician, could contribute to the individual's cognitive impairment [e.g., kidney disease, liver disease, brain tumor, alcohol or drug abuse, abnormal thyroid function, hydrocephalus normotensive, vascular dementia, neurocognitive disorder due to head trauma (according to the diagnostic criteria of the DSM V)];
- transient ischemic attack or stroke during the 12 months preceding screening; history of unstable angina, myocardial infarction, heart failure (New York Heart Association Class III or IV), or clinically significant heart rhythm disturbances documented within one year of screening;
- history of malignant tumor disease, except: cancer in remission for more than 5 years since screening; prostate cancer in situ;
- history of surgically treated squamous cell carcinoma or basal cell carcinoma;
- impaired liver function or liver failure;
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- history or evidence of autoimmune disease considered clinically significant by the doctor or requiring the chronic use of corticosteroids or other immunosuppressive drugs;
- clinically significant systemic illness or infection within 30 days of screening; comorbidity for primary psychiatric or neurological disorders;
- absence of an informant (partner, relative, adult child or friend) who knows the subject well enough to be able to provide reliable information on his cognitive and functional abilities.
- contraindication to carrying out the MRI exam.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Neuroimaging Network: Optimization and Harmonization of Advanced MRI Sequences and Their Application in the Study of Dementia and Intellectual Disability in Pediatric Age
Development of a shared multimodal MRI protocol for the definition and quantification of imaging biomarkers in AD, DLB, FDT dementias, especially white matter alterations.
Read the detailed description
Development of a shared multimodal MRI protocol for the definition and quantification of imaging biomarkers in AD, DLB, FDT dementias, especially white matter alterations.
- Conditions
- Dementia Frontal, Dementia Alzheimers, Lewy Body Variant of Alzheimer Disease, Neuro-Degenerative Disease
- Being tested
- AD FDT DBL GROUP
- Medical subject headings
- Alzheimer Disease, Lewy Body Variant of Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD FDT DBL GROUPDiagnostic test
All participants will undergo an MRI session. The MRI protocol will include the clinical diagnostic protocol defined within the Network and research sequences as specified above (T1 3D, DTI, FLAIR 3D, QSM).
| Study group | Role | What they receive |
|---|---|---|
| AD FDT DBL GROUP | All participants will undergo an MRI session. The MRI protocol will include the clinical diagnostic protocol defined within the Network and research sequences as specified above (T1 3D, DTI, FLAIR 3D, QSM). Receives: Diagnostic Test: AD FDT DBL GROUP | |
| CONTROL GROUP | All participants will undergo an MRI session. The MRI protocol will include the clinical diagnostic protocol defined within the Network and research sequences as specified above (T1 3D, DTI, FLAIR 3D, QSM). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Susceptibility Mapping (QSM), Diffusion Weighted Imaging (DWI) - Diffusion Tensor Imaging (DTI), Fluid Attenuated Inversion Recovery (FLAIR)
The main endpoint is the characterization of white matter alterations in different forms of dementing diseases through the combined study of MRI sequences. Specifically, we correlate Voxel Based Morphometry indices, DTI quantifcation and lesions volume with MMSE and MOCA scores.
Measured: during MRI procedure
Secondary outcomes (1)
FLAIR, QSM, DWI (DTI) for white matter study
Quantitative analysis of FLAIR, QSM, DWI (DTI) for white matter evaluation
ES2. Characterization of white matter alterations which will also take place through the quantification of:
- microstructure and macrostructure values of the white matter through diffusion techniques (including DTI)
- white matter lesions through post-processing algorithms (14) applied to the FLAIR sequence;
- magnetic susceptibility in the white matter and in particular in myelin (15), through the QSM technique;
ES3. Definition of an automatic single-case multimodal algorithm (MUQUBIA) for the quantification and classification of subjects with alterations of the white matter (as emerged from MRI data) useful for doctors in the Network.
ES4. Evaluation of variables of interest emerging from MRI analyzes in relation to clinical and neuropsychological variables
Measured: during MRI procedureRMN date examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start10 Jan 2019
- Primary completion22 Dec 2020
- Study completion10 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia FrontalStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217237
- Sponsor's protocol ID
- RETEimaging_IRCCS_001
- Status last verified
- Oct 2023
- First submitted
- 21 Mar 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Neuroimaging Network: Optimization and Harmonization of Advanced MRI Sequences and Their Application in the Study of Dementia and Intellectual Disability in Pediatric Age
- ClinicalTrials.gov ID
- NCT06217237
- Acronym / sponsor ID
- RETEimaging_IRCCS_001
- Conditions
- Dementia Frontal, Dementia Alzheimers, Lewy Body Variant of Alzheimer Disease, Neuro-Degenerative Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 22 Jan 2024 (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.
Development of a shared multimodal MRI protocol for the definition and quantification of imaging biomarkers in AD, DLB, FDT dementias, especially white matter alterations.
Detailed description
Development of a shared multimodal MRI protocol for the definition and quantification of imaging biomarkers in AD, DLB, FDT dementias, especially white matter alterations.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AD FDT DBL GROUP | – | Diagnostic Test: AD FDT DBL GROUPAll participants will undergo an MRI session. The MRI protocol will include the clinical diagnostic protocol defined within the Network and research sequences as specified above (T1 3D, DTI, FLAIR 3D, QSM). |
| CONTROL GROUP | – | –All participants will undergo an MRI session. The MRI protocol will include the clinical diagnostic protocol defined within the Network and research sequences as specified above (T1 3D, DTI, FLAIR 3D, QSM). |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and controls recruited based on the inclusion criteria carry out clinical and neuropsychological tests
Key inclusion criteria (11 listed)
- for patients
- accident cases
- time of onset of NOT MORE THAN 24 months
- Clinical Dementia Rating Scale (CDR) <=2;
- MoCA<=17
Key exclusion criteria (10 listed)
- for all
- any uncontrolled medical condition or neurological/neurodegenerative disease that, in the opinion of the recruiting physician, could contribute to the individual's cognitive impairment [e.g., kidney disease, liver disease, brain tumor, alcohol or drug abuse, abnormal thyroid function, hydrocephalus normotensive, vascular dementia, neurocognitive disorder due to head trauma (according to the diagnostic criteria of the DSM V)];
- transient ischemic attack or stroke during the 12 months preceding screening; history of unstable angina, myocardial infarction, heart failure (New York Heart Association Class III or IV), or clinically significant heart rhythm disturbances documented within one year of screening;
- history of malignant tumor disease, except: cancer in remission for more than 5 years since screening; prostate cancer in situ;
- history of surgically treated squamous cell carcinoma or basal cell carcinoma;
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 |
|---|---|---|
| AD FDT DBL GROUPAll participants will undergo an MRI session. The MRI protocol will include the clinical diagnostic protocol defined within the Network and research sequences as specified above (T1 3D, DTI, FLAIR 3D, QSM). | Diagnostic test | AD FDT DBL GROUP |
Primary outcome
Quantitative Susceptibility Mapping (QSM), Diffusion Weighted Imaging (DWI) - Diffusion Tensor Imaging (DTI), Fluid Attenuated Inversion Recovery (FLAIR)
Time frame: during MRI procedure
The main endpoint is the characterization of white matter alterations in different forms of dementing diseases through the combined study of MRI sequences. Specifically, we correlate Voxel Based Morphometry indices, DTI quantifcation and lesions volume with MMSE and MOCA scores.
1 secondary outcome
FLAIR, QSM, DWI (DTI) for white matter study
Time frame: during MRI procedureRMN date examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: Undecided. Corresponding author
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Dementia Frontal and Dementia Alzheimers, run by IRCCS Centro Neurolesi Bonino Pulejo 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 11 inclusion and 10 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: finished, as of the sponsor's last update on 22 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Susceptibility Mapping (QSM), Diffusion Weighted Imaging (DWI) - Diffusion Tensor Imaging (DTI), Fluid Attenuated Inversion Recovery (FLAIR) (time frame: during MRI procedure). 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 22 Jan 2024.