Trial record 3 of 10 for:    DIAN

F 18 T807 Tau PET Imaging in Dominantly Inherited Alzheimer's Network (DIAN Project)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Tammie Benzinger, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02414178
First received: April 7, 2015
Last updated: April 9, 2015
Last verified: April 2015
  Purpose

The purpose of this research study is to evaluate a new radioactive compound used in positron emission tomography (PET) scans in identifying tau tangles (a certain protein that might be associated with Dominantly Inherited Alzheimer's Disease) in the brain, and if the amount of tau tangles in the brain has a relationship to cognitive status.

This study involves a PET scans using the radioactive compound, F 18 T807 for measurement of tau deposition. This radioactive compound is not approved by the United States Food and Drug Administration (FDA). An MRI may also be conducted.


Condition Intervention Phase
Alzheimer Disease
Drug: F 18 T807
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: F 18 T807 Tau PET Imaging in Dominantly Inherited Alzheimer's Network (IND #123119 Protocol D)

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: February 2015
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental F 18 T807 Drug: F 18 T807
Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.
Other Name: 18F-AV-1451

Detailed Description:

The investigators hypothesize that in vivo tau imaging will ultimately:

  • Demonstrate the presence of tau fibrils in the brain during the pre-symptomatic stages of cognitive decline, prior to cerebral atrophy, hypometabolism (as measured by 18F-FDG PET imaging), and dementia.
  • Demonstrate that the phenoconversion from cognitively normal (CN) status to early stages of cognitive impairment will be closely correlated with neocortical F 18 T807 uptake and that amyloid positive CN individuals who are positive for F 18 T807 will demonstrate conversion to early dementia.
  • Correlate closely with the appearance of CSF markers of tau, including tau, p-tau, and VILIP-1.
  • Co-localize with specific cognitive deficits (i.e. patients with tau deposition in the left lateral temporal lobe will have primarily language deficits).
  • Predict the onset of dementia more accurately than existing biomarkers.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants have met all eligibility criteria for enrollment into "Dominantly Inherited Alzheimer's Network (DIAN) Performance Site" (IRB ID: 201109187)
  2. Male or female participants, at least 18 years of age
  3. Cognitively normal, or with mild dementia, as assessed clinically
  4. Participant is able and willing to undergo testing (MRI or CT, PET, radioactive tracer injection; for those unable to undergo an MRI, CT will be used to generate regions-of-interest).
  5. Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration.

Exclusion Criteria:

  1. Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures).
  2. Is deemed likely unable to perform the imaging procedures for any reason.
  3. Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
  4. Has hypersensitivity to F 18 T807 or any of its excipients.
  5. Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
  6. Severe claustrophobia.
  7. Currently pregnant or breast-feeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02414178

Contacts
Contact: Trish Stevenson, MS, CCRC 314 362-3613 stevensonp@mir.wustl.edu
Contact: Kelley Jackson, BA 314 362-6737 jacksonk@mir.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Trish Stevenson    314-362-3613    stevensonp@mir.wustl.edu   
Contact: Kelley Jackson    314 362-6737    jacksonk@mir.wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Tammie Benzinger, MD, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Tammie Benzinger, Associate Professor of Radiology & Neurological Surger, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02414178     History of Changes
Other Study ID Numbers: IND 123119 Protocol D
Study First Received: April 7, 2015
Last Updated: April 9, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
Dementia
Brain Diseases
Central Nervous System Diseases
Mild Cognitive Impairment
nervous system diseases
Neurodegenerative Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on July 30, 2015