NCT04579120 Neuroimaging in Healthy Aging and Senile Dementia (HASD_IND)
| NCT ID | NCT04579120 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tammie L. S. Benzinger, MD, PhD |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 650 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 650 participants in total. It began in 2021-09-01 with a primary completion date of 2027-11.
⚠ 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
To identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD).
Eligibility Criteria
Inclusion Criteria: * Male or female, any race * Age \> 18 years * Participation in one of the ongoing projects affiliated with the Knight ADRC at Washington University and referred by the MAP staff and a Washington University physician. * Normal cognition or early-stage symptomatic AD * Willing and able to undergo study procedures. * Capacity to give informed consent and follow study procedures Exclusion Criteria: * Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., participants with severe chronic back pain might not be able to lie still during the scanning procedures); * Has hypersensitivity to either AV-1451 or PIB or any of its excipients; * Contraindications to PET, CT or MRI (e.g. electronic medical devices, inability to lie still for extended periods) that make it unsafe for the individual to participate; * Severe claustrophobia; * Currently pregnant or breast-feeding. Women must agree to avoid becoming pregnant and must agree to refrain from sexual activity or to use reliable contraceptive methods for 24 hours following administration of Flortaucipir injection; * Must not have participated in any clinical trial involving a study drug or device within the 30-days prior to study enrollment; * Must not participate in another drug or device study prior to the end of this study participation; * Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1
Contact & Investigator
Tammie Benzinger, MD, PhD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT04579120 clinical trial?
This trial is open to participants of all sexes, aged 18 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.
Is NCT04579120 currently recruiting?
Yes, NCT04579120 is actively recruiting participants. Contact the research team at kelleyj@wustl.edu for enrollment information.
Where is the NCT04579120 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT04579120 clinical trial?
NCT04579120 is sponsored by Tammie L. S. Benzinger, MD, PhD. The principal investigator is Tammie Benzinger, MD, PhD at Washington University School of Medicine. The trial plans to enroll 650 participants.
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