Longitudinal Evaluation of [18F]GTP1 as a PET Radioligand for Imaging Tau in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants
NCT ID: NCT02640092
Last Updated: 2019-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2015-12-23
2019-06-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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[18F]GTP1
Participants will complete \[18F\]GTP1 PET imaging at four time points: Baseline, 6 months, 12 months and 18 months. For each \[18F\]GTP1 imaging session, the following procedure will be performed: a catheter will be placed for intravenous (IV) administration of \[18F\]GTP1. Participants will receive an IV bolus injection of up to 370 megabecquerel (MBq) (10 millicurie \[mCi\]) of \[18F\]GTP1.
[18F]GTP1
Participants will receive \[18F\]GTP1 as per the schedule specified in the arm description.
Interventions
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[18F]GTP1
Participants will receive \[18F\]GTP1 as per the schedule specified in the arm description.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\- Availability of a study partner who, in the investigator's judgment, has frequent and sufficient contact with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to accompany the participant and provide information at visits
For Healthy Participants:
* Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the Baseline \[18F\]GTP1 imaging visit
* Have no cognitive complaint
* Have a Clinical Dementia Rating Scale (CDR) global score = 0
* Have a Mini-Mental State Examination (MMSE) score of 28-30
For Participants With a Diagnosis of AD:
* Participants with mild or moderate AD must meet National Institute on Aging - Alzheimer's Association (NIA-AA) core clinical criteria for probable AD dementia, with an amnestic presentation
* Participants with prodromal AD must meet NIA-AA core clinical criteria for mild cognitive impairment (MCI)
* Have screening \[18F\]florbetapir PET imaging demonstrating amyloid binding based on qualitative visual read
Exclusion Criteria
* Satisfy one of the following subgroups: Approximately 20 prodromal AD (MMSE 24-30, CDR = 0.5); Approximately 20 mild AD (MMSE 22-30, CDR = 0.5 or 1); Approximately 20 moderate AD (MMSE 16-21, CDR = 0.5 or 1 or 2)
* Current or prior history of any drug or alcohol abuse
* Participants with any significant psychiatric, neurological, or unstable medical disorder expected to interfere with the study
* Participants unable to undergo MRI and PET scan
* For participants contributing CSF samples, any contraindication to lumbar puncture
* Prior participation in other research protocols or clinical care in the last year such a radiation exposure combined with that from the present study exceeds an effective dose of 50 millisievert (mSV), the allowable annual limit for research participants as stipulated by the Food and Drug Administration (FDA)
50 Years
85 Years
ALL
Yes
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Molecular NeuroImaging
New Haven, Connecticut, United States
KI Health Partners, LLC; New England Institute for Clinical Research
Stamford, Connecticut, United States
Neuropsychiatric Research; Center of Southwest Florida
Fort Myers, Florida, United States
Miami Jewish Health Systems
Miami, Florida, United States
Bioclinica Research
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
NeuroStudies.net, LLC
Decatur, Georgia, United States
Acadia Clinical Research; Dr. Henderson's Office
Bangor, Maine, United States
Donald S. Marks, M.D., P.C.; Medical Center
Plymouth, Massachusetts, United States
Alzheimers Disease Center
Quincy, Massachusetts, United States
NeuroCognitive Institute
Mount Arlington, New Jersey, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Advanced Medical Research
Maumee, Ohio, United States
Lehigh Center Clinical Research
Allentown, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Butler Hospital
Providence, Rhode Island, United States
Countries
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References
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Sanabria Bohorquez SM, Baker S, Manser PT, Tonietto M, Galli C, Wildsmith KR, Zou Y, Kerchner GA, Weimer R, Teng E. Evaluation of partial volume correction and analysis of longitudinal [18F]GTP1 tau PET imaging in Alzheimer's disease using linear mixed-effects models. Front Neuroimaging. 2024 Mar 28;3:1355402. doi: 10.3389/fnimg.2024.1355402. eCollection 2024.
Teng E, Manser PT, Sanabria Bohorquez S, Wildsmith KR, Pickthorn K, Baker SL, Ward M, Kerchner GA, Weimer RM. Baseline [18F]GTP1 tau PET imaging is associated with subsequent cognitive decline in Alzheimer's disease. Alzheimers Res Ther. 2021 Dec 1;13(1):196. doi: 10.1186/s13195-021-00937-x.
Blennow K, Chen C, Cicognola C, Wildsmith KR, Manser PT, Bohorquez SMS, Zhang Z, Xie B, Peng J, Hansson O, Kvartsberg H, Portelius E, Zetterberg H, Lashley T, Brinkmalm G, Kerchner GA, Weimer RM, Ye K, Hoglund K. Cerebrospinal fluid tau fragment correlates with tau PET: a candidate biomarker for tangle pathology. Brain. 2020 Feb 1;143(2):650-660. doi: 10.1093/brain/awz346.
Other Identifiers
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G0097
Identifier Type: OTHER
Identifier Source: secondary_id
GN30009
Identifier Type: -
Identifier Source: org_study_id