Cognitive Impairment, MildPhase 2NCT06723015
Tau PET Outcomes With Anti-amyloid Immunotherapies
A Phase 2 study testing 18F-AV-1451 and C-11 ER-176 in people with Cognitive Impairment, Mild and Dementia, Mild, run by Mayo Clinic at 1 site in United States.
Trial summary
This is an imaging study of patients with mild Alzheimer's disease receiving amyloid-targeting therapy and under the care of neurologists at Mayo Clinic in Rochester, MN. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cognitive Impairment, Mild, Dementia, Mild, Alzheimer Disease
- What is being tested?
- 18F-AV-1451 and C-11 ER-176
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2025to Aug 2028
- Phase
- Phase 2
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-90 years
- Male or female
- Mild cognitive impairment due to AD or mild AD
- Amyloid positive via CSF or PET
- Meets other eligibility criteria for anti-amyloid immunotherapy
- Subject or delegate provides informed consent
Who cannot join
- Subjects unable to lie down without moving for 10 minutes.
- Women who are pregnant or cannot stop breast feeding for 24 hours.
- Claustrophobic patients unable to tolerate the scans (no sedation can be offered).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study of Tau PET Outcomes in Patients Receiving Anti-amyloid Immunotherapies
This is an imaging study of patients with mild Alzheimer's disease receiving amyloid-targeting therapy and under the care of neurologists at Mayo Clinic in Rochester, MN.
- Being tested
- 18F-AV-1451, C-11 ER-176
- Medical subject headings
- Cognitive Dysfunction, Dementia, Lymphoma, Follicular, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-AV-1451Drug
Subjects will receive two Tau PET (18F--AV-1451) brain scans with approximately 10 mCi (370 MBq) (+/- 10%mCi) of 18F-AV-1451. Images will be collected for a 20-minute acquisition between 80-100 minutes after injection.
Tau PET scans will occur at baseline and 12-18 months after completing anti-amyloid immunotherapy treatment..
C-11 ER-176Drug
For the optional TSPO PET scans, C-11 ER176 will be administered as a single time IV injection prior to PET imaging. The injected dose of C-11 ER176 will be 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Untreated historical controls enrolled in Mayo Clinic Study of Aging (IRB 14-004401), Mayo Alzheimer's Disease Research Center (IRB 712-98), and Brain Amyloid Imaging with Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia (IRB 08-005553). |
| Treatment Group | Experimental | Subjects with a diagnosis of mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease and amyloid positive, who are starting anti-amyloid immunotherapy. Receives: Drug: 18F-AV-1451; Drug: C-11 ER-176 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tau PET Standardized Uptake Value (SUVR)
A PET Standardized Uptake Value (SUV) is measured by calculating the ratio of the radioactivity concentration within a specific region of interest (ROI) on a PET scan, divided by the injected dose of the radiotracer per unit of the patient's body weight. The calculated Standardized Uptake Value (SUVR) is reported as a single number, with higher values indicating greater tracer uptake in the target region relative to the reference region
Measured: Baseline, 18 months
Secondary outcomes (1)
Number of subjects to develop amyloid-related imaging abnormalities (ARIA)
ARIA is defined as edema (parenchymal edema or sulcal effusion, ARIA-E) and hemorrhage (microhemorrhages and superficial siderosis, ARIA-H). ARIA is detected on the patient's routine clinical brain MRIs.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start4 Nov 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Impairment, MildStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petrice M. Cogswell, Mayo Clinic
- Investigators
- Petrice Cogswell, M.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723015
- Sponsor's protocol ID
- 24-004371
- Status last verified
- Nov 2025
- First submitted
- 5 Dec 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Tau PET Outcomes in Patients Receiving Anti-amyloid Immunotherapies
- ClinicalTrials.gov ID
- NCT06723015
- Acronym / sponsor ID
- 24-004371
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 9 Dec 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.
This is an imaging study of patients with mild Alzheimer's disease receiving amyloid-targeting therapy and under the care of neurologists at Mayo Clinic in Rochester, MN.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Untreated historical controls enrolled in Mayo Clinic Study of Aging (IRB 14-004401), Mayo Alzheimer's Disease Research Center (IRB 712-98), and Brain Amyloid Imaging with Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia (IRB 08-005553). |
| Treatment Group | Experimental | Drug: 18F-AV-1451, Drug: C-11 ER-176Subjects with a diagnosis of mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease and amyloid positive, who are starting anti-amyloid immunotherapy. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 50-90 years
- Male or female
- Mild cognitive impairment due to AD or mild AD
- Amyloid positive via CSF or PET
- Meets other eligibility criteria for anti-amyloid immunotherapy
Key exclusion criteria (3 listed)
- Subjects unable to lie down without moving for 10 minutes.
- Women who are pregnant or cannot stop breast feeding for 24 hours.
- Claustrophobic patients unable to tolerate the scans (no sedation can be offered).
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 |
|---|---|---|
| 18F-AV-1451Subjects will receive two Tau PET (18F--AV-1451) brain scans with approximately 10 mCi (370 MBq) (+/- 10%mCi) of 18F-AV-1451. Images will be collected for a 20-minute acquisition between 80-100 minutes after injection. Tau PET scans will occur at baseline and 12-18 months after completing anti-amyloid immunotherapy treatment.. | Drug | Treatment Group |
| C-11 ER-176For the optional TSPO PET scans, C-11 ER176 will be administered as a single time IV injection prior to PET imaging. The injected dose of C-11 ER176 will be 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi). | Drug | Treatment Group |
Primary outcome
Change in tau PET Standardized Uptake Value (SUVR)
Time frame: Baseline, 18 months
A PET Standardized Uptake Value (SUV) is measured by calculating the ratio of the radioactivity concentration within a specific region of interest (ROI) on a PET scan, divided by the injected dose of the radiotracer per unit of the patient's body weight. The calculated Standardized Uptake Value (SUVR) is reported as a single number, with higher values indicating greater tracer uptake in the target region relative to the reference region
1 secondary outcome
Number of subjects to develop amyloid-related imaging abnormalities (ARIA)
Time frame: 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 30 Oct 2026.
- 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.
Petrice Cogswell, M.D., Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-AV-1451 and C-11 ER-176 in people with Cognitive Impairment, Mild and Dementia, Mild, run by Mayo Clinic at 1 site in United States.
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 6 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 30 Oct 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Change in tau PET Standardized Uptake Value (SUVR) (time frame: Baseline, 18 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 30 Oct 2026.