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Tau Imaging in Young Onset Dementia

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ClinicalTrials.gov Identifier: NCT02289118
Recruitment Status : Active, not recruiting
First Posted : November 13, 2014
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease, Early Onset Logopenic Progressive Aphasia Posterior Cortical Atrophy (PCA) Drug: [18F]-T807 imaging tracer Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: [18F]-T807 PET/CT Imaging of Tau Pathology in Young Onset Focal Dementia
Actual Study Start Date : November 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 31, 2019


Arm Intervention/treatment
Experimental: Diagnostic Imaging
[18F]T807 imaging tracer.
Drug: [18F]-T807 imaging tracer
Tau Imaging tracer
Other Name: AV-1451




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289118


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: David Wolk, MD University of Pennsylvania

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02289118     History of Changes
Other Study ID Numbers: 820665
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Dementia
Alzheimer Disease
Atrophy
Aphasia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Pathological Conditions, Anatomical
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms