Skip to main content
OpenTrials
Completed

NCT Number: NCT02289118

Tau Imaging in Young Onset Dementia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants will be 45 - 70 years of age
  • MMSE > 10 at screening visit.
  • 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.
  • Participants must be willing and able to comply with scheduled visits and imaging procedures.
  • 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
  • Participants must identify a study partner who is willing to accompany the patient to study visits

Exclusion criteria

  • 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
  • Inability to tolerate or contraindication to imaging procedures (PET/CT or MRI) in the opinion of an investigator or treating physician
  • QTc > 450 msec on screening ECG.
  • 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)).

Treatment and study plan

[18F]-T807 imaging tracer

Drug

Tau Imaging tracer

Other names: AV-1451

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. Correlate [18F]T807 binding based on standardized uptake value ratio (SUVr) with standard cognitive tests.

    Time frame: 2 years

    Neurocognitive test results

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

[18F]-T807 PET/CT Imaging of Tau Pathology in Young Onset Focal Dementia

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Nov 13, 2014
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.