94 Participants Needed

Diagnostic Imaging for Tauopathies

Eo
RM
Overseen ByRefatun Momo
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Amyloid PET scan for diagnosing tauopathies?

Amyloid PET scans are effective in identifying amyloid-positive patients, which is useful for early-stage Alzheimer's disease diagnosis and clinical trial enrollment. This imaging technique helps in detecting early cerebral amyloidosis, a key feature of Alzheimer's, and can improve diagnostic confidence and patient management.12345

Is diagnostic imaging for tauopathies, like Amyloid PET scans and Brain MRI, safe for humans?

Amyloid PET imaging, used to detect amyloid-beta in the brain, has been approved by the FDA since 2012 and is considered a non-invasive and safe technique for diagnosing Alzheimer's disease and other conditions. It is widely used in clinical practice and research, with no significant safety concerns reported in the studies reviewed.12678

How is the diagnostic imaging treatment for tauopathies different from other treatments?

The diagnostic imaging treatment for tauopathies is unique because it uses advanced imaging techniques like PET scans to visualize tau deposits in the brain, which helps in early and accurate diagnosis. Unlike traditional treatments that focus on managing symptoms, this approach aids in identifying the specific type of neurodegenerative disease, potentially leading to more targeted interventions.19101112

What is the purpose of this trial?

This current protocol will provide the key data to help determine the specificity of our to-be-developed radiotracers by implementing a multi-site diagnostic assessment core and PET imaging of A-beta amyloid (may be completed at some sites as part of another protocol) that is commonly deposited in the brains of people with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP) or Frontotemporal Dementia (FTD) as well as healthy controls. This multicenter U19 grant is centered at U Pennsylvania (U Penn) (PI: Robert Mach) in collaboration with U Pittsburgh (Pitt), Yale University, U of California at San Francisco (UCSF) and Washington University in St. Louis (WU). U Penn will act as the single IRB of Record (sIRB) for this multi-center project and subjects will be recruited from all sites.

Eligibility Criteria

This trial is for adults aged 40-85 with Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, Frontotemporal Dementia or healthy controls. They must understand the study and consent to participate. Pregnant women and those with major psychiatric disorders or substance abuse issues are excluded.

Inclusion Criteria

Participants must be willing to participate in the study in accordance with institutional and federal guidelines
Participants must be informed of the investigational nature of the study and be willing to provide written informed consent
A group of experts will decide if you have a specific brain condition (PD, MSA, PSP, FTD) or if you are a healthy control.
See 2 more

Exclusion Criteria

You have a serious mental illness like schizophrenia or bipolar disorder.
Contraindications or inability to tolerate imaging, arterial line or IV placement or blood draw procedures in the opinion of an investigator or treating physician
I am not pregnant or breastfeeding.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Assessment

Subjects may receive a brain MRI and neurological exam with diagnostic assessments

8 weeks
Multiple visits for imaging and assessments

Follow-up

Participants are monitored for safety and effectiveness after diagnostic assessments

4 weeks

Treatment Details

Interventions

  • Amyloid PET scan
  • Brain MRI Scan
  • Neurologic exam
Trial Overview The trial tests new radiotracers' specificity using diagnostic assessments like neurologic exams and brain scans (Amyloid PET and MRI) across multiple sites including U Penn, Pitt, Yale University, UCSF, and WU.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Diagnostic AssessmentsExperimental Treatment2 Interventions
Subjects may receive a brain MRI and neurological exam with diagnostic assessments.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Findings from Research

In a phase 1b trial involving 278 patients with early stages of Alzheimer's disease, amyloid PET imaging successfully identified 61% of patients as amyloid-positive, making it a promising tool for selecting participants for clinical trials.
The study found that ApoE ε4 carriers were more likely to be amyloid-positive (80%) compared to noncarriers (43%), highlighting the potential of PET imaging to enrich trial populations based on genetic risk factors.
Amyloid PET Screening for Enrichment of Early-Stage Alzheimer Disease Clinical Trials: Experience in a Phase 1b Clinical Trial.Sevigny, J., Suhy, J., Chiao, P., et al.[2022]
Amyloid PET imaging can lead to significant changes in the diagnosis of Alzheimer's disease, with a pooled estimate showing a 31% change rate across 16 studies involving various patient populations.
The imaging technique also increases diagnostic confidence and influences patient management decisions, particularly in cases where there is high diagnostic uncertainty, affecting treatment plans for Alzheimer's medications.
A Review of Diagnostic Impact of Amyloid Positron Emission Tomography Imaging in Clinical Practice.Kim, Y., Rosenberg, P., Oh, E.[2019]
Human amyloid imaging using PET scans allows for the detection of early cerebral amyloidosis, a key feature of Alzheimer's disease, potentially leading to earlier diagnosis.
While initial data is promising, it is important to interpret amyloid PET results carefully, as the presence of amyloidosis does not necessarily indicate clinical Alzheimer's disease or predict immediate cognitive decline.
Amyloid imaging of Alzheimer's disease using Pittsburgh Compound B.Johnson, KA.[2019]

References

Amyloid PET Screening for Enrichment of Early-Stage Alzheimer Disease Clinical Trials: Experience in a Phase 1b Clinical Trial. [2022]
A Review of Diagnostic Impact of Amyloid Positron Emission Tomography Imaging in Clinical Practice. [2019]
Amyloid imaging of Alzheimer's disease using Pittsburgh Compound B. [2019]
Psychosocial and Behavioral Outcomes for Persons With Cognitive Impairment and Caregivers Following Amyloid-β PET Scan Disclosure: A Systematic Review. [2023]
A Systematic Review and Aggregated Analysis on the Impact of Amyloid PET Brain Imaging on the Diagnosis, Diagnostic Confidence, and Management of Patients being Evaluated for Alzheimer's Disease. [2023]
[Amyloid imaging]. [2016]
Use of amyloid PET across the spectrum of Alzheimer's disease: clinical utility and associated ethical issues. [2020]
Amyloid imaging: the court of public opinion. [2018]
[Amyloid imaging]. [2016]
10.United Statespubmed.ncbi.nlm.nih.gov
The Role of Neuroimaging in the Assessment of the Cognitively Impaired Elderly. [2018]
Imaging Clinical Subtypes and Associated Brain Networks in Alzheimer's Disease. [2022]
Technical Considerations on Scanning and Image Analysis for Amyloid PET in Dementia. [2017]
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