Alzheimer's DiseaseMCPNCT05658913
Tau PET/CT Imaging in the Mismatch Prospective Cohort Study (MPC-TAU)
An observational study of Alzheimer's Disease, run by University of Pennsylvania at 2 sites in United States.
Trial summary
To collect Tau PET/CT imaging in older adults diagnosed with Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD) in the Mismatch Prospective Cohort Study (MPC-Tau) study to determine relationship to clinical, cognitive, and other biomarker data. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- AV-1451
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Mar 2023to Dec 2029
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population includes individuals with a clinical diagnosis of MCI or possible/probably AD
Who may be able to join
- Enrolled in MPC study (Protocol 850160 at UPenn; Protocol 2022P002447 at MGH).
- Reliable study partner to accompany participant to the PET/CT scan
- A brain MRI must be performed within 6 months prior to their study AV-1451 TAU PET/CT scan date and be deemed of adequate quality that the scan may be used for study analysis, including 3T high-resolution imaging of medial temporal lobe structures.
Who cannot join
- Have any medical or psychiatric conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
- Have evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with analysis of the PET/CT scan.
- Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician.
- Have a history of significant ongoing alcohol or substance abuse based on self- report.
- Female participants of child-bearing age will not be able to participate in this study, determined by self-report.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
Bradford Dickerson, MD, 617-726-6205, brad.dickerson@mgh.harvard.edu
Erin Krahn, 617-726-6205, ekrahn@mgh.harvard.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jackie Lane, 610-299-1243, Jacqueline.Lane@pennmedicine.upenn.edu
David Wolk, MD
About this study
To collect Tau PET/CT imaging in older adults diagnosed with Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD) in the Mismatch Prospective Cohort Study (MPC-Tau) study to determine relationship to clinical, cognitive, and other biomarker data. Findings from this study will likely provide insight into the phenotypic variability of Alzheimer's Disease and other related pathologies.
Read the detailed description
This is a cross-sectional study using the radiotracer AV-1451 to determine the relationship of tau pathology to other biomarker data of MPC participants. All subjects will already have been enrolled in the MPC Study. For the current protocol, participants will provide informed consent before beginning any study procedures. After screening assessments, participants will undergo PET/CT scan imaging with AV-1451.
- Conditions
- Alzheimer's Disease
- Being tested
- AV-1451
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV-1451Drug
Also called 7-(6-[18F]fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole
This is a cross-sectional study using the radiotracer AV-1451 to determine the relationship of tau pathology to other biomarker data of MPC participants.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clusters based on spatial pattern and extent of T-N Mismatch
We will test the hypotheses that spatial pattern and directionality of deviation in individual subjects of this metric will be correlated with modulatory factors such as non-AD pathology, brain resilience and vulnerability.
Specifically, we will use hierarchical clustering to determine groups based on degree and spatial pattern of mismatch between tau PET and cortical thickness measured by MRI. In these groups, we will compare amount of white matter hyperintensities, degree of brain aging, and both cross-sectional and longitudinal cognitive measures, with the primary measure being the Clinical Dementia Rating scale sum of boxes.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start14 Mar 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, David Wolk, University of Pennsylvania
- Investigators
- David A. Wolk, Principal investigator, University of Pennsylvania Department of Neurology at the Perelman School of MedicineSandhitsu R. Das, Principal investigator, University of Pennsylvania Department of Neurology at the Perelman School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658913
- Sponsor's protocol ID
- 850679
- Acronym
- MCP
- Status last verified
- Sep 2026
- First submitted
- 8 Dec 2022
- Last updated
- 4 Sep 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tau PET/CT Imaging in the Mismatch Prospective Cohort Study (MPC-TAU)
- ClinicalTrials.gov ID
- NCT05658913
- Acronym / sponsor ID
- MCP / 850679
- Conditions
- Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 21 Dec 2022 (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.
To collect Tau PET/CT imaging in older adults diagnosed with Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD) in the Mismatch Prospective Cohort Study (MPC-Tau) study to determine relationship to clinical, cognitive, and other biomarker data. Findings from this study will likely provide insight into the phenotypic variability of Alzheimer's Disease and other related pathologies.
Detailed description
This is a cross-sectional study using the radiotracer AV-1451 to determine the relationship of tau pathology to other biomarker data of MPC participants. All subjects will already have been enrolled in the MPC Study. For the current protocol, participants will provide informed consent before beginning any study procedures. After screening assessments, participants will undergo PET/CT scan imaging with AV-1451.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population includes individuals with a clinical diagnosis of MCI or possible/probably AD
Key inclusion criteria (3 listed)
- Enrolled in MPC study (Protocol 850160 at UPenn; Protocol 2022P002447 at MGH).
- Reliable study partner to accompany participant to the PET/CT scan
- A brain MRI must be performed within 6 months prior to their study AV-1451 TAU PET/CT scan date and be deemed of adequate quality that the scan may be used for study analysis, including 3T high-resolution imaging of medial temporal lobe structures.
Key exclusion criteria (5 listed)
- Have any medical or psychiatric conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
- Have evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with analysis of the PET/CT scan.
- Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician.
- Have a history of significant ongoing alcohol or substance abuse based on self- report.
- Female participants of child-bearing age will not be able to participate in this study, determined by self-report.
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 |
|---|---|---|
| AV-1451Also: 7-(6-[18F]fluoropyridin-3-yl)-5H-pyrido[4,3-b]indoleThis is a cross-sectional study using the radiotracer AV-1451 to determine the relationship of tau pathology to other biomarker data of MPC participants. | Drug | – |
Primary outcome
Clusters based on spatial pattern and extent of T-N Mismatch
Time frame: 5 years
We will test the hypotheses that spatial pattern and directionality of deviation in individual subjects of this metric will be correlated with modulatory factors such as non-AD pathology, brain resilience and vulnerability. Specifically, we will use hierarchical clustering to determine groups based on degree and spatial pattern of mismatch between tau PET and cortical thickness measured by MRI. In these groups, we will compare amount of white matter hyperintensities, degree of brain aging, and both cross-sectional and longitudinal cognitive measures, with the primary measure being the Clinical Dementia Rating scale sum of boxes.
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 4 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Alzheimer's Disease
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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.
David A. Wolk principal investigator
University of Pennsylvania Department of Neurology at the Perelman School of Medicine
Sandhitsu R. Das principal investigator
University of Pennsylvania Department of Neurology at the Perelman School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by University of Pennsylvania at 2 sites 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 3 inclusion and 5 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 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Jacqueline Lane (610-299-1243, Jacqueline.Lane@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clusters based on spatial pattern and extent of T-N Mismatch (time frame: 5 years). 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 4 Sep 2026.