Clinical trial NCT02289118: Tau Imaging in Young Onset Dementia
Official title: [18F]-T807 PET/CT Imaging of Tau Pathology in Young Onset Focal Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease, Early Onset
Logopenic Progressive Aphasia
Posterior Cortical Atrophy (PCA)
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2014-11-13
Enrollment: 16
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with early onset AD (symptoms preceding age 65)

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.


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)).

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
timeFrame: 2 years
measure: Correlate patterns of [18F]T807 binding based on standardized uptake value ratio (SUVr) with MRI-based regional volumetric (mm3) and cortical thickness (mm) measures
timeFrame: 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).
timeFrame: 2 years
measure: Correlate [18F]T807 binding based on standardized uptake value ratio (SUVr) with standard cognitive tests.
timeFrame: 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: David Wolk, MD
role: PRINCIPAL_INVESTIGATOR
References: