Tau Imaging in Young Onset Dementia

NCT02289118 | Completed

• 1 other identifier: 820665
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease, Early Onset; Logopenic Progressive Aphasia; Posterior Cortical Atrophy (PCA)

Outcome Measures

Primary Outcomes (2)

• 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

  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

  2 years

Secondary Outcomes (2)

• 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).

  2 years

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

  2 years

Study Arms (1)

Diagnostic Imaging

\[18F\]T807 imaging tracer.

Drug: [18F]-T807 imaging tracer

Interventions

[18F]-T807 imaging tracer DRUG

Tau Imaging tracer

Also known as: AV-1451

Diagnostic Imaging

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with early onset AD (symptoms preceding age 65)

You may qualify if:

• 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

You may not qualify if:

• 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)).

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• David Wolk, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 13, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: January 31, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

US (1)