Investigating brain changes in healthy aging and early Alzheimer's disease
Neuroimaging in Healthy Aging and Senile Dementia (HASD_IND)
This study is testing how brain changes in healthy older adults compare to those in people with early Alzheimer's disease to see if certain markers can help spot the disease earlier.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 650 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT04579120 on ClinicalTrials.gov |
What this trial studies
This research evaluates brain structure and function in healthy aging individuals and those with early Alzheimer's disease using advanced imaging techniques such as PET, MRI, and CT. The study aims to identify factors that indicate the transition from asymptomatic to symptomatic Alzheimer's disease by detecting amyloid deposits in the brain. Participants will undergo imaging with investigational radioactive tracers that bind to amyloid and tau proteins, which are associated with Alzheimer's pathology.
Who should consider this trial
Good fit: Ideal candidates include individuals over 18 years old with normal cognition or early-stage symptomatic Alzheimer's disease.
Not a fit: Patients with conditions that could interfere with imaging procedures or those with severe chronic pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and intervention strategies for Alzheimer's disease.
How similar studies have performed: Other studies using similar imaging techniques have shown promise in understanding Alzheimer's disease progression, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Tammie Benzinger, MD, PhD — Washington University School of Medicine
- Study coordinator: Kelley Jackson, BA
- Email: kelleyj@wustl.edu
- Phone: 314-362-1558
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.