Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tau Imaging in Young Onset Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02289118
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date November 5, 2014
First Posted Date November 13, 2014
Last Update Posted Date March 25, 2020
Actual Study Start Date November 2014
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 7, 2014)
  • Determine and compare the similarities and differences in regional brain uptake of [18F]T807 by using standardized uptake value ratio (SUVr) in patients with typical AD, PCA and lvPPA [ Time Frame: 2 years ]
  • Correlate patterns of [18F]T807 binding based on standardized uptake value ratio (SUVr) with MRI-based regional volumetric (mm3) and cortical thickness (mm) measures [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 7, 2014)
  • Correlate CSF markers of amyloid (Aβ1-42) and/or tau (total tau, phospho-tau) pathology (pg/mL) to uptake of [18F]T807 based on standardized uptake value ratio (SUVr). [ Time Frame: 2 years ]
  • Correlate [18F]T807 binding based on standardized uptake value ratio (SUVr) with standard cognitive tests. [ Time Frame: 2 years ]
    Neurocognitive test results
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Tau Imaging in Young Onset Dementia
Official Title [18F]-T807 PET/CT Imaging of Tau Pathology in Young Onset Focal Dementia
Brief Summary The central goal of this study is to determine and compare the similarities and differences in regional brain uptake of [18F]T807 in patients with typical Alzheimer's Disease (AD), Posterior Cortical Atrophy (PCA), and Logopenic Variant of Primary Progressive Aphasia (lvPPA). The investigators will correlate patterns of [18F]T807 binding with magnetic resonance imaging (MRI)-based regional volumetric and cortical thickness measures. If cerebral spinal fluid (CSF) samples are not available, patients may be asked to get an optional lumbar puncture (LP) for additional comparisons. The investigators will recruit 20 participants, 45-70 years old, with clinical evidence of young onset focal dementia.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with early onset AD (symptoms preceding age 65)
Condition
  • Alzheimer's Disease, Early Onset
  • Logopenic Progressive Aphasia
  • Posterior Cortical Atrophy (PCA)
Intervention Drug: [18F]-T807 imaging tracer
Tau Imaging tracer
Other Name: AV-1451
Study Groups/Cohorts Diagnostic Imaging
[18F]T807 imaging tracer.
Intervention: Drug: [18F]-T807 imaging tracer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 11, 2016)
16
Original Estimated Enrollment
 (submitted: November 7, 2014)
20
Actual Study Completion Date January 31, 2019
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Participants will be 45 - 70 years of age
  2. MMSE > 10 at screening visit.
  3. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. If the patient is unable to provide informed consent, the patient's legal representative may consent on behalf of the patient but the patient will be asked to confirm assent.
  4. Participants must be willing and able to comply with scheduled visits and imaging procedures.
  5. A brain MRI is required. If a brain MRI has been performed within 6 months of enrollment to this study and of adequate quality that scan may be used for the study analysis, subjects who do not have a brain MRI will undergo a brain MRI either as a part of this study
  6. Participants must identify a study partner who is willing to accompany the patient to study visits

Exclusion Criteria:

  1. Females who are pregnant or breast feeding at the time of screening scan will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening
  2. Inability to tolerate or contraindication to imaging procedures (PET/CT or MRI) in the opinion of an investigator or treating physician
  3. QTc > 450 msec on screening ECG.
  4. Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study (e.g. moderate to large stroke or history of moderate or severe traumatic brain injury (TBI)).
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02289118
Other Study ID Numbers 820665
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Pennsylvania
Study Sponsor University of Pennsylvania
Collaborators Not Provided
Investigators
Principal Investigator: David Wolk, MD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date March 2020