F 18 T807 Tau PET Imaging of Alzheimer's Disease

NCT02414347 | Recruiting

• 1 other identifier: IND 123119 Protocol A
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, open-label baseline controlled imaging study designed to assess whether brain tau fibril uptake of flortaucipir as measured by PET correlates with cognitive status of individuals with and without brain tau fibrils.

Conditions

Alzheimer Disease

Keywords

Dementia; Tauopathies; Brain Diseases; Central Nervous System Diseases; Mild Cognitive Impairment; Nervous System Diseases; Neurodegenerative Disease

Outcome Measures

Primary Outcomes (1)

• F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.

  Employing statistical parametric mapping (SPM), a voxel-based analytic measure in order to quantify and co-localize the imaging patterns from the multiple imaging datasets in this study.

  5 years

Study Arms (1)

Experimental F 18 T807

Participants will undergo a PET scan using the flortaucipir imaging tracer

Drug: F 18 T807

Interventions

F 18 T807 DRUG

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.

Also known as: 18F-AV-1451

Experimental F 18 T807

Eligibility Criteria

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

Study Population

One hundred (100) participants over a period of approximately 5 years will be enrolled. Participants will undergo an F 18 T807 scan at the Center for Clinical Imaging Research (CCIR) at Washington University using an adaption of the protocol developed by Kolb and colleagues \[7\]. An MRI may be conducted if one has not been completed within the past 12 months under a related research study.

You may qualify if:

• Male or female participants, at least 18 years of age.
• Cognitively normal, or with mild dementia, as assessed clinically
• Participant is able and willing to undergo testing (MRI or CT, PET, radioactive tracer injection, LP; for those unable to undergo an MRI, CT will be used to generate regions-of-interest).
• Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration.

You may not qualify if:

• 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).
• Is deemed likely unable to perform the imaging procedures for any reason.
• Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
• Has hypersensitivity to F 18 T807 or any of its excipients.
• 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.
• Severe claustrophobia.
• Currently pregnant or breast-feeding.
• For those electing to undergo the optional lumbar puncture: currently on anticoagulant of any form -

Sponsors & Collaborators

• Tammie L. S. Benzinger, MD, PhD: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (9)

• Day GS, Gordon BA, Perrin RJ, Cairns NJ, Beaumont H, Schwetye K, Ferguson C, Sinha N, Bucelli R, Musiek ES, Ghoshal N, Ponisio MR, Vincent B, Mishra S, Jackson K, Morris JC, Benzinger TLS, Ances BM. In vivo [18F]-AV-1451 tau-PET imaging in sporadic Creutzfeldt-Jakob disease. Neurology. 2018 Mar 6;90(10):e896-e906. doi: 10.1212/WNL.0000000000005064. Epub 2018 Feb 7.

  PMID: 29438042 BACKGROUND

• Mishra S, Gordon BA, Su Y, Christensen J, Friedrichsen K, Jackson K, Hornbeck R, Balota DA, Cairns NJ, Morris JC, Ances BM, Benzinger TLS. AV-1451 PET imaging of tau pathology in preclinical Alzheimer disease: Defining a summary measure. Neuroimage. 2017 Nov 1;161:171-178. doi: 10.1016/j.neuroimage.2017.07.050. Epub 2017 Jul 26.

  PMID: 28756238 BACKGROUND

• Roe CM, Babulal GM, Mishra S, Gordon BA, Stout SH, Ott BR, Carr DB, Ances BM, Morris JC, Benzinger TLS. Tau and Amyloid Positron Emission Tomography Imaging Predict Driving Performance Among Older Adults with and without Preclinical Alzheimer's Disease. J Alzheimers Dis. 2018;61(2):509-513. doi: 10.3233/JAD-170521.

  PMID: 29171997 BACKGROUND

• Gordon BA, McCullough A, Mishra S, Blazey TM, Su Y, Christensen J, Dincer A, Jackson K, Hornbeck RC, Morris JC, Ances BM, Benzinger TLS. Cross-sectional and longitudinal atrophy is preferentially associated with tau rather than amyloid beta positron emission tomography pathology. Alzheimers Dement (Amst). 2018 Mar 6;10:245-252. doi: 10.1016/j.dadm.2018.02.003. eCollection 2018.

  PMID: 29780869 BACKGROUND

• Roe CM, Babulal GM, Stout SH, Ott BR, Carr DB, Williams MM, Benzinger TLS, Fagan AM, Holtzman DM, Ances BM, Morris JC. Using the A/T/N Framework to Examine Driving in Preclinical AD. Geriatrics (Basel). 2018 Jun;3(2):23. doi: 10.3390/geriatrics3020023. Epub 2018 May 2.

  PMID: 29805967 BACKGROUND

• Strain JF, Smith RX, Beaumont H, Roe CM, Gordon BA, Mishra S, Adeyemo B, Christensen JJ, Su Y, Morris JC, Benzinger TLS, Ances BM. Loss of white matter integrity reflects tau accumulation in Alzheimer disease defined regions. Neurology. 2018 Jul 24;91(4):e313-e318. doi: 10.1212/WNL.0000000000005864. Epub 2018 Jun 29.

  PMID: 29959265 BACKGROUND

• Aschenbrenner AJ, Gordon BA, Benzinger TLS, Morris JC, Hassenstab JJ. Influence of tau PET, amyloid PET, and hippocampal volume on cognition in Alzheimer disease. Neurology. 2018 Aug 28;91(9):e859-e866. doi: 10.1212/WNL.0000000000006075. Epub 2018 Aug 1.

  PMID: 30068637 BACKGROUND

• Pontecorvo MJ, Devous MD Sr, Navitsky M, Lu M, Salloway S, Schaerf FW, Jennings D, Arora AK, McGeehan A, Lim NC, Xiong H, Joshi AD, Siderowf A, Mintun MA; 18F-AV-1451-A05 investigators. Relationships between flortaucipir PET tau binding and amyloid burden, clinical diagnosis, age and cognition. Brain. 2017 Mar 1;140(3):748-763. doi: 10.1093/brain/aww334.

  PMID: 28077397 BACKGROUND

• Zhao Y, Raichle ME, Wen J, Benzinger TL, Fagan AM, Hassenstab J, Vlassenko AG, Luo J, Cairns NJ, Christensen JJ, Morris JC, Yablonskiy DA. In vivo detection of microstructural correlates of brain pathology in preclinical and early Alzheimer Disease with magnetic resonance imaging. Neuroimage. 2017 Mar 1;148:296-304. doi: 10.1016/j.neuroimage.2016.12.026. Epub 2016 Dec 15.

  PMID: 27989773 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Tauopathies; Brain Diseases; Central Nervous System Diseases; Cognitive Dysfunction; Nervous System Diseases; Neurodegenerative Diseases

Interventions

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

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Tammie Benzinger, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelley M Jackson, BA

CONTACT

314 362-1558; kelleyj@wustl.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology & Neurological Surgery

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 10, 2015
• Study Start: October 23, 2014
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)