NCT03809351 UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy
| NCT ID | NCT03809351 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Alabama at Birmingham |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2020-07-08 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 160 participants in total. It began in 2020-07-08 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol. 2. 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. 3. 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: 1. Meets any exclusion criteria for the UAB-ADC study. 2. Inability or contraindication for undergoing MRI and/or PET imaging 3. Inability to participate in the imaging studies due to severity of dementia
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03809351 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03809351 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03809351 currently recruiting?
Yes, NCT03809351 is actively recruiting participants. Contact the research team at cdosse@uabmc.edu for enrollment information.
Where is the NCT03809351 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT03809351 clinical trial?
NCT03809351 is sponsored by University of Alabama at Birmingham. The trial plans to enroll 160 participants.
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