Alzheimer DiseaseADRCproj1NCT03287765
Evaluating the Relationship Between Tau PET Imaging and CSF Biomarkers of AD (Alzheimer Disease) in Humans
An observational study of Alzheimer Disease, run by Tammie L. S. Benzinger, MD, PhD at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate a new radioactive compound used in positron emission tomography (PET) scans in identifying tau tangles (a certain protein that might be associated with Alzheimer's disease) in the brain, and if the amount of tau tangles in the brain has a relationship to cerebrospinal… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- 18F-AV-1451
- Type of treatment
- Injection or infusion
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 19 Jul 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Under this study protocol, collaborating physicians and the Knight Alzheimer's Disease Research Center (ADRC) Clinical Core will refer participants to the Knight ADRC Research Imaging (KARI) Program for MR and PET imaging to evaluate tau distribution in the brains of cognitively normal and cognitively impaired individuals.
Who may be able to join
- Male or female participants, at least 65 years of age.
- Participant is willing to undergo a lumbar puncture (LP) or has previously undergone LP. LP will be conducted under IRB ID 201109100 (PI: Anne Fagan).
- Participant is able and willing to undergo positron emission tomography (PET) and magnetic resonance imaging (MRI) of the brain.
- Pre-menopausal women must have a negative urine pregnancy test within 24 hours preceding T807 drug administration.
Who cannot join
- Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures).
- Is deemed likely unable to perform the imaging procedures for any reason.
- Has a history of Torsades de Pointes or is taking medications known to prolong or may prolong QT interval (refer to study's list of restricted medications).
- Has known hypersensitivity to T807 or any of its excipients.
- Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
- Severe claustrophobia.
- Currently pregnant or breast-feeding. -
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Evaluating the Relationship Between Tau PET Imaging and CSF Biomarkers of AD in Humans
The purpose of this research study is to evaluate a new radioactive compound used in positron emission tomography (PET) scans in identifying tau tangles (a certain protein that might be associated with Alzheimer's disease) in the brain, and if the amount of tau tangles in the brain has a relationship to cerebrospinal fluid (CSF) biomarkers and cognitive status.
This study involves a PET scans using the radioactive compound, F 18 T807 for measurement of tau deposition. This radioactive compound is not approved by the United States Food and Drug Administration (FDA). An MRI will be conducted if one has not been completed completed within the past 12 months under a related research study. Participants will be asked about their medical history, family history, surgical history, and current medications. We will evaluate history of traumatic brain injury (TBI) using the Ohio State University Traumatic Brain Injury Identification (OSU TBI-ID) Method. This will take approximately 10 minutes. Participants will be asked to undergo a Mini Mental State Examination (MMSE), which will last approximately 5-10 minutes.
Additionally, participants may be invited to undergo optional brain PET imaging with 2-deoxy-2-[18F]fluoro-D-glucose fludeoxyglucose (18F-FDG), for measurement of the cerebral metabolic rate of glucose consumption. At the time of the initial T807-PET study, participants will be asked if they are willing to undergo repeat T807-PET imaging at least 2 years after the initial study. This follow up study is optional, and participation in the study and initial T807-PET imaging will not be contingent on agreeing to the 2-year follow up study.
- Conditions
- Alzheimer Disease
- Being tested
- 18F-AV-1451
- Keywords
- Dementia, Tauopathies, cognitive impairment, CNS Diseases, neurodegenerative disease
- Medical subject headings
- Alzheimer Disease, Dementia, Tauopathies, Cognitive Dysfunction, Central Nervous System Diseases, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-AV-1451Drug
Also called Flortauapir
Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.
| Study group | Role | What they receive |
|---|---|---|
| Experimental 18F-AV-1451 | Not described Receives: Drug: 18F-AV-1451 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the association among T807-PET measures of PHF-tau.
Measured: 5 years
Characterize the amount and spatial distribution of T807-PET measures in healthy aging. preclinical AD, and early symptomatic AD.
Measured: 5 years
Characterize the amount and spatial distribution of T807-PET measures in preclinical AD.
Measured: 5 years
Characterize the amount and spatial distribution of T807-PET measures in early symptomatic AD.
Measured: 5 years
Examine the association among T807-PET measures of concentrations of CSF biomarkers. and cognitive performance.
Measured: 5 years
Examine the association among T807-PET measures of cognitive performance.
Measured: 5 years
Secondary outcomes (1)
Evaluate the change in T807-PET measures over time in asymptomatic amyloid-positive individuals and its association with changes in concentrations of CSF biomarkers.
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 posted19 Sep 2017
- Study startMay 2016
- Primary completionMay 2021
- Study completion19 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tammie L. S. Benzinger, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tammie L. S. Benzinger, MD, PhD, Washington University School of Medicine
- Investigators
- Tammie Benzinger, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287765
- Sponsor's protocol ID
- IND123119,Protocol F
- Acronym
- ADRCproj1
- Status last verified
- May 2023
- First submitted
- 31 Oct 2016
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The Investigators may share the participant's data with other researchers that may be doing research in areas similar to this research or in other unrelated areas. These researchers may be at Washington University, at other research centers and institutions, or industry sponsors of research. The Investigators may also share the research data with large data repositories (a repository is a database of information) for broad sharing with the research community. If the individual research data is placed in one of these repositories only qualified researchers will be able to look at the information.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Relationship Between Tau PET Imaging and CSF Biomarkers of AD in Humans
- ClinicalTrials.gov ID
- NCT03287765
- Acronym / sponsor ID
- ADRCproj1 / IND123119,Protocol F
- Conditions
- Alzheimer Disease
- Keywords
- Dementia, Tauopathies, cognitive impairment, CNS Diseases, neurodegenerative disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Tammie L. S. Benzinger, MD, PhDUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- 19 Jul 2021 (actual)
- First posted
- 19 Sep 2017 (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.
The purpose of this research study is to evaluate a new radioactive compound used in positron emission tomography (PET) scans in identifying tau tangles (a certain protein that might be associated with Alzheimer's disease) in the brain, and if the amount of tau tangles in the brain has a relationship to cerebrospinal fluid (CSF) biomarkers and cognitive status.
This study involves a PET scans using the radioactive compound, F 18 T807 for measurement of tau deposition. This radioactive compound is not approved by the United States Food and Drug Administration (FDA). An MRI will be conducted if one has not been completed completed within the past 12 months under a related research study. Participants will be asked about their medical history, family history, surgical history, and current medications. We will evaluate history of traumatic brain injury (TBI) using the Ohio State University Traumatic Brain Injury Identification (OSU TBI-ID) Method. This will take approximately 10 minutes. Participants will be asked to undergo a Mini Mental State Examination (MMSE), which will last approximately 5-10 minutes.
Additionally, participants may be invited to undergo optional brain PET imaging with 2-deoxy-2-[18F]fluoro-D-glucose fludeoxyglucose (18F-FDG), for measurement of the cerebral metabolic rate of glucose consumption. At the time of the initial T807-PET study, participants will be asked if they are willing to undergo repeat T807-PET imaging at least 2 years after the initial study. This follow up study is optional, and participation in the study and initial T807-PET imaging will not be contingent on agreeing to the 2-year follow up study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental 18F-AV-1451 | – | Drug: 18F-AV-1451 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Under this study protocol, collaborating physicians and the Knight Alzheimer's Disease Research Center (ADRC) Clinical Core will refer participants to the Knight ADRC Research Imaging (KARI) Program for MR and PET imaging to evaluate tau distribution in the brains of cognitively normal and cognitively impaired individuals.
Key inclusion criteria (4 listed)
- Male or female participants, at least 65 years of age.
- Participant is willing to undergo a lumbar puncture (LP) or has previously undergone LP. LP will be conducted under IRB ID 201109100 (PI: Anne Fagan).
- Participant is able and willing to undergo positron emission tomography (PET) and magnetic resonance imaging (MRI) of the brain.
- Pre-menopausal women must have a negative urine pregnancy test within 24 hours preceding T807 drug administration.
Key exclusion criteria (7 listed)
- Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures).
- Is deemed likely unable to perform the imaging procedures for any reason.
- Has a history of Torsades de Pointes or is taking medications known to prolong or may prolong QT interval (refer to study's list of restricted medications).
- Has known hypersensitivity to T807 or any of its excipients.
- Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
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-1451Also: FlortauapirParticipants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. | Drug | Experimental 18F-AV-1451 |
Primary outcome
Examine the association among T807-PET measures of PHF-tau.
Time frame: 5 years
Characterize the amount and spatial distribution of T807-PET measures in healthy aging. preclinical AD, and early symptomatic AD.
Time frame: 5 years
Characterize the amount and spatial distribution of T807-PET measures in preclinical AD.
Time frame: 5 years
Characterize the amount and spatial distribution of T807-PET measures in early symptomatic AD.
Time frame: 5 years
Examine the association among T807-PET measures of concentrations of CSF biomarkers. and cognitive performance.
Time frame: 5 years
Examine the association among T807-PET measures of cognitive performance.
Time frame: 5 years
1 secondary outcome
Evaluate the change in T807-PET measures over time in asymptomatic amyloid-positive individuals and its association with changes in concentrations of CSF biomarkers.
Time frame: 5 years
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 8 May 2023.
- Individual participant dataSharing planned: Yes. The Investigators may share the participant's data with other researchers that may be doing research in areas similar to this research or in other unrelated areas. These researchers may be at Washington University, at other research centers and institutions, or industry sponsors of research. The Investigators may also share the research data with large data repositories (a repository is a database of information) for broad sharing with the research community. If the individual research data is placed in one of these repositories only qualified researchers will be able to look at the information.
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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.
Tammie Benzinger, MD, PhD principal investigator
Washington University School of Medicine
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 Alzheimer Disease, run by Tammie L. S. Benzinger, MD, PhD 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 4 inclusion and 7 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 8 May 2023. 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.
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?
Examine the association among T807-PET measures of PHF-tau. (time frame: 5 years). The study lists 6 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 8 May 2023.