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出境医 / 临床实验 / UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy (AV1451 ADC)
UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy (AV1451 ADC)
Study Description
Brief Summary:
The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic tau deposition using the PET tracer AV-1451 in participants in the UAB-ADC cohort. The amount and distribution of AV-1451 in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain tau levels measured with AV-1451-PET, and cognitive status will be the primary outcome of this imaging study. Individuals participating in this AV-1451-PET/MRI study will also be enrolled in an ongoing [C-11]PiB-PET/MRI study (IRB-300001005, IND-138128), and their amyloid, tau and cognitive statuses will be compared in terms of race and vascular risk factors.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer Disease | Drug: [F-18]AV-1451-PET | Phase 1 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 160 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy |
| Actual Study Start Date : | July 8, 2020 |
| Estimated Primary Completion Date : | July 8, 2022 |
| Estimated Study Completion Date : | July 8, 2024 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: [F-18]AV-1451-PET/MRI
All participants in this study will undergo a tau-PET imaging using the tracer [F-18]AV-1451 with a simultaneous PET/MRI system. The [F-18]AV-1451 dosage is 740MBq (10 mCi) given intravenously, and the PET/MRI imaging will occur 75-105 min after tracer injection.
|
Drug: [F-18]AV-1451-PET
All study participants will undergo brain imaging with [F-18]AV-1451-PET/MRI. [F-18]AV-1451 is a PET imaging agent used primarily to measure the amount of abnormal tau protein deposition the brain.
|
Outcome Measures
Primary Outcome Measures :
- Measurement of pathological tau deposition in the brain. [ Time Frame: 5 years ]The amount and regional distribution of pathological tau in the brains of study participants will be measured with [F-18]AV-1451-PET/MRI using standardized uptake value ratios (SUVRs) derived from the PET images.
Eligibility Criteria
| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Enrollment in the UAB-ADC study under a separate IRB-approved research protocol.
- Enrollment in the UAB-ADC amyloid-PET substudy under a separate IRB-approved research protocol. The amyloid-PET study does not have to have been completed prior to enrollment and participation in this tau-PET study.
- Negative urine or serum hCG test within 2 days of [F-18]AV-1451 administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.
Exclusion Criteria:
- Meets any exclusion criteria for the UAB-ADC study.
- Inability or contraindication for undergoing MRI and/or PET imaging
- Inability to participate in the imaging studies due to severity of dementia
Contacts and Locations
Contacts
| Contact: Jonathan McConathy, MD, PhD | 205-996-7115 | jmcconathy@uabmc.edu | |
| Contact: April Riddle, RT | 205-934-6504 | ariddle@uabmc.edu |
Locations
| United States, Alabama | |
| UAB | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: April Riddle 205-934-6504 ariddle@uabmc.edu | |
Sponsors and Collaborators
University of Alabama at Birmingham
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | January 14, 2019 | ||||||||
| First Posted Date ICMJE | January 18, 2019 | ||||||||
| Last Update Posted Date | July 29, 2020 | ||||||||
| Actual Study Start Date ICMJE | July 8, 2020 | ||||||||
| Estimated Primary Completion Date | July 8, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Measurement of pathological tau deposition in the brain. [ Time Frame: 5 years ] The amount and regional distribution of pathological tau in the brains of study participants will be measured with [F-18]AV-1451-PET/MRI using standardized uptake value ratios (SUVRs) derived from the PET images.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy | ||||||||
| Official Title ICMJE | UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy | ||||||||
| Brief Summary | The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic tau deposition using the PET tracer AV-1451 in participants in the UAB-ADC cohort. The amount and distribution of AV-1451 in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain tau levels measured with AV-1451-PET, and cognitive status will be the primary outcome of this imaging study. Individuals participating in this AV-1451-PET/MRI study will also be enrolled in an ongoing [C-11]PiB-PET/MRI study (IRB-300001005, IND-138128), and their amyloid, tau and cognitive statuses will be compared in terms of race and vascular risk factors. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
||||||||
| Condition ICMJE | Alzheimer Disease | ||||||||
| Intervention ICMJE | Drug: [F-18]AV-1451-PET
All study participants will undergo brain imaging with [F-18]AV-1451-PET/MRI. [F-18]AV-1451 is a PET imaging agent used primarily to measure the amount of abnormal tau protein deposition the brain.
|
||||||||
| Study Arms ICMJE | Experimental: [F-18]AV-1451-PET/MRI
All participants in this study will undergo a tau-PET imaging using the tracer [F-18]AV-1451 with a simultaneous PET/MRI system. The [F-18]AV-1451 dosage is 740MBq (10 mCi) given intravenously, and the PET/MRI imaging will occur 75-105 min after tracer injection.
Intervention: Drug: [F-18]AV-1451-PET
|
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
160 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 8, 2024 | ||||||||
| Estimated Primary Completion Date | July 8, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 50 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03809351 | ||||||||
| Other Study ID Numbers ICMJE | R19-006 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Jonathan E McConathy, University of Alabama at Birmingham | ||||||||
| Study Sponsor ICMJE | University of Alabama at Birmingham | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | University of Alabama at Birmingham | ||||||||
| Verification Date | July 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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