Overview

This trial is active, not recruiting.

Conditions alzheimer's disease, early onset, logopenic progressive aphasia, posterior cortical atrophy (pca)
Treatment [18f]-t807 imaging tracer
Sponsor University of Pennsylvania
Start date November 2014
End date November 2016
Trial size 16 participants
Trial identifier NCT02289118, 820665

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
[18F]T807 imaging tracer.
[18f]-t807 imaging tracer AV-1451
Tau Imaging tracer

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 45 years up to 70 years old.

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)).

Additional Information

Official title [18F]-T807 PET/CT Imaging of Tau Pathology in Young Onset Focal Dementia
Principal investigator David Wolk, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.