NCT03503331 UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy
| NCT ID | NCT03503331 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Alabama at Birmingham |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2018-04-20 |
| Primary Completion | 2028-10 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 160 participants in total. It began in 2018-04-20 with a primary completion date of 2028-10.
⚠ 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 amyloid deposition using the PET tracer \[C-11\]PiB in participants in the UAB Alzheimer's Disease Center cohort. Assessment of interactions between race and vascular risk factors, brain amyloid levels measured with \[C-11\]PiB-PET, and cognitive status will be the primary outcome of this imaging study.
Eligibility Criteria
Inclusion Criteria: \- 1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol (IRB-300000169). 2\. Negative urine or serum B-hCG test within 2 days of \[C-11\]PiB 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 (IRB-300000169). 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
Jonathan McConathy, MD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT03503331 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 NCT03503331 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03503331 currently recruiting?
Yes, NCT03503331 is actively recruiting participants. Contact the research team at cdosse@uabmc.edu for enrollment information.
Where is the NCT03503331 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT03503331 clinical trial?
NCT03503331 is sponsored by University of Alabama at Birmingham. The principal investigator is Jonathan McConathy, MD at University of Alabama at Birmingham. The trial plans to enroll 160 participants.
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