Alzheimer Dementia (AD)NCT07456462
Making Antibody Treatments More Effective in Early Alzheimer's Disease Using 3Tesla Magnetica Resonance
A study testing MRI assessment and blood sample collection in people with Alzheimer Dementia (AD) and Mild Cognitive Impairment (MCI), run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Alzheimer's disease causes progressive memory and cognitive decline, driven in part by the buildup of a protein called β-amyloid in the brain. New antibody therapies - lecanemab and donanemab - can remove amyloid and slow down the disease in its early stages. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Alzheimer Dementia (AD), Mild Cognitive Impairment (MCI)
- What is being tested?
- MRI assessment and blood sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2026to 1 May 2029
- Phase
- Interventional
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1Participant is willing and able to give informed consent for participation in the study.
- 2. Participant is eligible for anti-amyloid therapy (AAT), i.e.:
- Participants aged 30-90.
- Diagnosis of early symptomatic AD, including MCI or mild dementia [2].
- Global Clinical Dementia Rating (CDR) score of 0.5 or 1.0
- Confirmed amyloid pathology through CSF or PET imaging. 3. Participant is willing to start Anti-amyloid therapy as part of his/her clinical-practice- therapeutic plan.
- 4. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional four weeks after the end of study.
- 5. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
Who cannot join
- 1. Contraindications to AAT, including:
- Significant neurological diseases other than AD that could affect cognition or study participation (e.g., other dementias, serious brain infections, Parkinson's disease, multiple concussions, epilepsy with recurrent seizures).
- Homozygous ApoE4 genotype.
- Current use of anticoagulant therapy.
- Vascular abnormalities: Presence of more than 4 microhemorrhages (defined as ≤10 mm in greatest diameter), a single macrohemorrhage >10 mm, superficial siderosis, evidence of vasogenic edema, multiple lacunar infarcts, or stroke involving a major vascular territory.
- Amyloid-Related Imaging Abnormalities (ARIA): Evidence of ARIA, including cerebral amyloid angiopathy-related inflammation (CAA-ri) or amyloid beta-related angiitis (ABRA).
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- Bleeding disorders: History of bleeding disorders not under adequate control, including a platelet count <50,000 or international normalized ratio (INR) >1.5 for participants not on anticoagulant therapy.
- Being currently under treatment with another AAT other than lecanemab/donanemab (e.g. as part of a Clinical Trial).
- 2. Current serious or unstable illnesses, including:
- Cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic diseases.
- Conditions that, in the clinician's opinion, could interfere with study analyses or with a life expectancy of less than 24 months.
- History of cancer within the last 5 years, except for non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer, or other cancers with low risk of recurrence.
- 3. Inability to undergo MRI or PET imaging procedures (e.g. non-MRI safe pacemaker or devices, claustrophobia etc).
- 4. Women of childbearing potential who are not using adequate contraception, as well as pregnant or breastfeeding women.
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
San Raffaele Neurology Unit
Milan, Milano, 20132
Federica Agosta, MD, 0226433051, agosta.federica@hsr.it
Filippi Massimo, Prof
About this study
Official title: Precision Monitoring and Predictive Models for Optimizing Monoclonal Antibody Therapy in Early Alzheimer's Disease - A Prospective Monocenter Interventional Study on 3T MRI
Alzheimer's disease causes progressive memory and cognitive decline, driven in part by the buildup of a protein called β-amyloid in the brain. New antibody therapies - lecanemab and donanemab - can remove amyloid and slow down the disease in its early stages. However, it is still unclear how long each patient should continue treatment or when it is safe to stop, because amyloid is cleared at different rates across individuals.
Today, amyloid Positron Emission Tomography (PET) scans are used to measure whether amyloid has been removed from the brain, but these scans are expensive, not always available, and expose patients to radiation. Since repeated PET scans are not ideal, doctors need better ways to monitor treatment progress.
Read more
This study will use advanced brain Magnetic Resonance Imaging (MRI) and blood tests to create personalized prediction models. These models will simulate how amyloid spreads or clears in each person's brain and help identify when treatment is still needed. With this approach, monitoring becomes safer, more efficient, and more affordable - helping ensure that each patient receives the right treatment for the right amount of time.
This prospective monocenter study investigates the role of 3Tesla MRI-based predictive modeling in predicting treatment response to anti-amyloid monoclonal antibodies (lecanemab or donanemab administered as clinical practice) in 50 patients with early Alzheimer's disease (AD) at IRCCS Ospedale San Raffaele (Milan, Italy). Advanced MRI techniques, including high- resolution structural imaging for cortical thickness and volumetric atrophy, diffusion imaging for structural connectivity, and resting-state functional MRI for functional network analysis, will be acquired at baseline, 6, 12, and 18 months.
These multimodal MRI measures will be integrated into computational approaches, such as the Aggregation Network Diffusion (AND) model, to simulate individual disease trajectories and predict the probability of achieving negativity at amyloid PET under treatment.
While serial [¹⁸F]Flutemetamol PET will be performed as part of standard clinical practice to confirm amyloid removal, the focus of the study is on developing MRI- derived predictive biomarkers. The ultimate goal is to establish robust, non-invasive models capable of guiding individualized treatment monitoring and supporting evidence-based decisions on treatment discontinuation
Overall, the project aims to support more precise care for people with early Alzheimer's disease, while reducing unnecessary procedures and improving quality of life.
- Being tested
- MRI assessment and blood sample collection
- Keywords
- Alzheimer's disease, Amyloid, Monoclonal antibody therapy, Lecanemab, Donanemab, Precision medicine, Predictive modeling, 3 Tesla Magnetic Resonance, Amyloid Tomography Emission Positron (PET), Plasma biomarkers
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI assessment and blood sample collectionOther
Participants will undergo non-contrast-enhanced 3T MRI, including structural, diffusion, and functional sequences, to assess brain atrophy, connectivity, and other imaging markers relevant to disease progression and treatment response.
Peripheral venous blood will be collected at scheduled study visits to measure plasma biomarkers associated with amyloid, tau, and neurodegeneration, providing complementary information on treatment effects through a minimally invasive method.
Eventually, multimodal predictive models, using the Aggregation Network Diffusion (AND) model, based on baseline amyloid burden, structural and functional brain connectivity, and clinical, cognitive and plasma biomarkers will be developed to estimate the time to significant amyloid reduction in patients with MCI or mild AD treated with lecanemab or donanemab
| Study group | Role | What they receive |
|---|---|---|
| Participants with Alzheimer's disease and Mild Cognitive Impairment (MCI) | Experimental | Participants with AD or MCI receiving monoclonal antibody therapy (lecanemab or donanemab) administered as clinical practice. Receives: Other: MRI assessment and blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predicting time (in months) to amyloid [¹⁸F]Flutemetamol (amyloid) PET negativity on a single scan
Predicting time (in months) to amyloid [¹⁸F]Flutemetamol (amyloid) PET negativity, defined as amyloid load <11 Centiloids on a single scan
Measured: baseline, 6 months, 12 months and 18 months
Predicting time (in months) to amyloid [¹⁸F]Flutemetamol (amyloid) PET negativity on two consecutive scans
Predicting time (in months) to amyloid [¹⁸F]Flutemetamol (amyloid) PET negativity, defined as amyloid load -<25 Centiloids on two consecutive scans
Measured: Baseline, 6 months, 12 months, 18 months
Secondary outcomes (14)
Change in regional cerebral perfusion expressed in Standardized Uptake Volume Ratio (SUVR)
Change in regional cerebral perfusion expressed in SUVR (as a proxy from early-phase [¹⁸F]Flutemetamol - amyloid PET)
Measured: 6 months, 12 months, 18 months
Change in global cerebral perfusion expressed in Standardized Uptake Volume Ratio (SUVR)
Change in global cerebral perfusion expressed in SUVR (as a proxy from early-phase [¹⁸F]Flutemetamol - amyloid PET)
Measured: 6 months, 12 months, 18 months
Longitudinal change in brain volume
Evaluating brain volume changes over time
Measured: 6 months, 12 months, 18 months
Longitudinal change in white matter integrity via Neurite Orientation Dispersion and Density Imaging (NODDI)
Evaluating structural white matter integrity over time
Measured: 6 months, 12 months, 18 months
Longitudinal change in brain connectivity via functional MRI
Evaluating functional brain changes over time with whole brain statistics analysis
Measured: 6 months, 12 months, 18 months
Change from baseline in plasma biomarkers Aβ42/Aβ40
Evaluating the correlation between plasma biomarkers with imaging-based measures of amyloid reduction and brain network alterations.
Measured: 6 months, 12 months, 18 months
Change from baseline in plasma biomarkers pTau217
Evaluating the correlation between plasma biomarkers with imaging-based measures of amyloid reduction and brain network alterations.
Measured: 6 months, 12 months, 18 months
Changes from baseline in plasma biomarkers pTau181
Evaluating the correlation between plasma biomarkers with imaging-based measures of amyloid reduction and brain network alterations.
Measured: 6 months, 12 months, 18 months
Changes from baseline in plasma biomarkers NfL
Evaluating the correlation between plasma biomarkers with imaging-based measures of amyloid reduction and brain network alterations.
Measured: 6 months, 12 months, 18 months
Changes from baseline in plasma biomarkers GFAP
Evaluating the correlation between plasma biomarkers with imaging-based measures of amyloid reduction and brain network alterations.
Measured: 6 months, 12 months, 18 months
Change from baseline in Mini Mental Score examination (MMSE)
Neuropsychological assessment aimed at evaluating changes in cognitive performance and their association with neuroimaging and biomarker trajectories
Measured: 6 months, 12 months, 18 months
Change from baseline in Alzheimer's Disease Assessment Scale's cognitive score (ADAS-Cog)
Change in ADAS-Cog's score and its association with neuroimaging and biomarker trajectories
Measured: 6 months, 12 months, 18 months
Change from baseline in Clinical Dementia's Rating scale's cognitive score (CDR)
Change in CDR's score and its association with neuroimaging and biomarker trajectories
Measured: 6 months, 12 months, 18 months
Change from baseline in Clinical Dementia Rating-Sum of Boxes' cognitive score (CDRsb)
Change in CDRsb's score and its association with neuroimaging and biomarker trajectories
Measured: 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Dementia (AD)Studies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional study on procedure (3T brain MRI)
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Massimo Filippi, IRCCS San Raffaele
- Investigators
- Massimo Filippi, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456462
- Sponsor's protocol ID
- AMYTRACK
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Monitoring and Predictive Models for Optimizing Monoclonal Antibody Therapy in Early Alzheimer's Disease - A Prospective Monocenter Interventional Study on 3T MRI
- ClinicalTrials.gov ID
- NCT07456462
- Acronym / sponsor ID
- AMYTRACK
- Keywords
- Alzheimer's disease, Amyloid, Monoclonal antibody therapy, Lecanemab, Donanemab, Precision medicine, Predictive modeling, 3 Tesla Magnetic Resonance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 6 Mar 2026 (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.
Alzheimer's disease causes progressive memory and cognitive decline, driven in part by the buildup of a protein called β-amyloid in the brain. New antibody therapies - lecanemab and donanemab - can remove amyloid and slow down the disease in its early stages. However, it is still unclear how long each patient should continue treatment or when it is safe to stop, because amyloid is cleared at different rates across individuals.
Today, amyloid Positron Emission Tomography (PET) scans are used to measure whether amyloid has been removed from the brain, but these scans are expensive, not always available, and expose patients to radiation. Since repeated PET scans are not ideal, doctors need better ways to monitor treatment progress.
This study will use advanced brain Magnetic Resonance Imaging (MRI) and blood tests to create personalized prediction models. These models will simulate how amyloid spreads or clears in each person's brain and help identify when treatment is still needed. With this approach, monitoring becomes safer, more efficient, and more affordable - helping ensure that each patient receives the right treatment for the right amount of time.
This prospective monocenter study investigates the role of 3Tesla MRI-based predictive modeling in predicting treatment response to anti-amyloid monoclonal antibodies (lecanemab or donanemab administered as clinical practice) in 50 patients with early Alzheimer's disease (AD) at IRCCS Ospedale San Raffaele (Milan, Italy). Advanced MRI techniques, including high- resolution structural imaging for cortical thickness and volumetric atrophy, diffusion imaging for structural connectivity, and resting-state functional MRI for functional network analysis, will be acquired at baseline, 6, 12, and 18 months.
These multimodal MRI measures will be integrated into computational approaches, such as the Aggregation Network Diffusion (AND) model, to simulate individual disease trajectories and predict the probability of achieving negativity at amyloid PET under treatment.
While serial [¹⁸F]Flutemetamol PET will be performed as part of standard clinical practice to confirm amyloid removal, the focus of the study is on developing MRI- derived predictive biomarkers. The ultimate goal is to establish robust, non-invasive models capable of guiding individualized treatment monitoring and supporting evidence-based decisions on treatment discontinuation
Overall, the project aims to support more precise care for people with early Alzheimer's disease, while reducing unnecessary procedures and improving quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional study on procedure (3T brain MRI)
| Arm | Type | Receives |
|---|---|---|
| Participants with Alzheimer's disease and Mild Cognitive Impairment (MCI) | Experimental | Other: MRI assessment and blood sample collectionParticipants with AD or MCI receiving monoclonal antibody therapy (lecanemab or donanemab) administered as clinical practice. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1Participant is willing and able to give informed consent for participation in the study.
- Participants aged 30-90.
- Diagnosis of early symptomatic AD, including MCI or mild dementia [2].
- Global Clinical Dementia Rating (CDR) score of 0.5 or 1.0
- Confirmed amyloid pathology through CSF or PET imaging. 3. Participant is willing to start Anti-amyloid therapy as part of his/her clinical-practice- therapeutic plan.
Key exclusion criteria (14 listed)
- 1. Contraindications to AAT, including:
- 3. Inability to undergo MRI or PET imaging procedures (e.g. non-MRI safe pacemaker or devices, claustrophobia etc).
- 4. Women of childbearing potential who are not using adequate contraception, as well as pregnant or breastfeeding women.
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 |
|---|---|---|
| MRI assessment and blood sample collectionParticipants will undergo non-contrast-enhanced 3T MRI, including structural, diffusion, and functional sequences, to assess brain atrophy, connectivity, and other imaging markers relevant to disease progression and treatment response. Peripheral venous blood will be collected at scheduled study visits to measure plasma biomarkers associated with amyloid, tau, and neurodegeneration, providing complementary information on treatment effects through a minimally invasive method. Eventually, multimodal predictive models, using the Aggregation Network Diffusion (AND) model, based on baseline amyloid burden, structural and functional brain connectivity, and clinical, cognitive and plasma biomarkers will be developed to estimate the time to significant amyloid reduction in patients with MCI or mild AD treated with lecanemab or donanemab | Other | Participants with Alzheimer's disease and Mild Cognitive Impairment (MCI) |
Primary outcome
Predicting time (in months) to amyloid [¹⁸F]Flutemetamol (amyloid) PET negativity on a single scan
Time frame: baseline, 6 months, 12 months and 18 months
Predicting time (in months) to amyloid [¹⁸F]Flutemetamol (amyloid) PET negativity, defined as amyloid load <11 Centiloids on a single scan
Predicting time (in months) to amyloid [¹⁸F]Flutemetamol (amyloid) PET negativity on two consecutive scans
Time frame: Baseline, 6 months, 12 months, 18 months
Predicting time (in months) to amyloid [¹⁸F]Flutemetamol (amyloid) PET negativity, defined as amyloid load -<25 Centiloids on two consecutive scans
14 secondary outcomes
Change in regional cerebral perfusion expressed in Standardized Uptake Volume Ratio (SUVR)
Time frame: 6 months, 12 months, 18 months
Change in global cerebral perfusion expressed in Standardized Uptake Volume Ratio (SUVR)
Time frame: 6 months, 12 months, 18 months
Longitudinal change in brain volume
Time frame: 6 months, 12 months, 18 months
Longitudinal change in white matter integrity via Neurite Orientation Dispersion and Density Imaging (NODDI)
Time frame: 6 months, 12 months, 18 months
Longitudinal change in brain connectivity via functional MRI
Time frame: 6 months, 12 months, 18 months
Change from baseline in plasma biomarkers Aβ42/Aβ40
Time frame: 6 months, 12 months, 18 months
Change from baseline in plasma biomarkers pTau217
Time frame: 6 months, 12 months, 18 months
Changes from baseline in plasma biomarkers pTau181
Time frame: 6 months, 12 months, 18 months
Changes from baseline in plasma biomarkers NfL
Time frame: 6 months, 12 months, 18 months
Changes from baseline in plasma biomarkers GFAP
Time frame: 6 months, 12 months, 18 months
Change from baseline in Mini Mental Score examination (MMSE)
Time frame: 6 months, 12 months, 18 months
Change from baseline in Alzheimer's Disease Assessment Scale's cognitive score (ADAS-Cog)
Time frame: 6 months, 12 months, 18 months
Change from baseline in Clinical Dementia's Rating scale's cognitive score (CDR)
Time frame: 6 months, 12 months, 18 months
Change from baseline in Clinical Dementia Rating-Sum of Boxes' cognitive score (CDRsb)
Time frame: 6 months, 12 months, 18 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 6 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Massimo Filippi principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI assessment and blood sample collection in people with Alzheimer Dementia (AD) and Mild Cognitive Impairment (MCI), run by IRCCS San Raffaele 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 8 inclusion and 14 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: opening soon, as of the sponsor's last update on 6 Mar 2026. 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?
Contact Federica FA Agosta, MD (0226433051, agosta.federica@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predicting time (in months) to amyloid [¹⁸F]Flutemetamol (amyloid) PET negativity on a single scan (time frame: baseline, 6 months, 12 months and 18 months). The study lists 2 primary outcomes in all. 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 6 Mar 2026.