- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02640092
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
Longitudinal Evaluation of [18F]GTP1 as a PET Radioligand for Imaging Tau in the Brain of Patients With Prodromal, Mild, and Moderate Alzheimer's Disease Compared to Healthy Volunteers
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06510
- Molecular NeuroImaging
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Stamford, Connecticut, United States, 06905
- KI Health Partners, LLC; New England Institute for Clinical Research
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Florida
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Fort Myers, Florida, United States, 33912
- Neuropsychiatric Research; Center of Southwest Florida
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Miami, Florida, United States, 33137
- Miami Jewish Health Systems
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Orlando, Florida, United States, 32806
- Bioclinica Research
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Georgia
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Atlanta, Georgia, United States, 30303
- Emory University
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Decatur, Georgia, United States, 30033
- NeuroStudies.net, LLC
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Maine
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Bangor, Maine, United States, 04401
- Acadia Clinical Research; Dr. Henderson's Office
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Massachusetts
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Plymouth, Massachusetts, United States, 02360
- Donald S. Marks, M.D., P.C.; Medical Center
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Quincy, Massachusetts, United States, 02169
- Alzheimers Disease Center
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New Jersey
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Mount Arlington, New Jersey, United States, 07856
- NeuroCognitive Institute
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Toms River, New Jersey, United States, 08755
- Bio Behavioral Health
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Ohio
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Maumee, Ohio, United States, 43537
- Advanced Medical Research
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Pennsylvania
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Allentown, Pennsylvania, United States, 18104
- Lehigh Center Clinical Research
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Rhode Island
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East Providence, Rhode Island, United States, 02914
- Rhode Island Mood & Memory Research Institute
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Providence, Rhode Island, United States, 02906
- Butler Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
For All Participants:
- 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
- A brain MRI consistent with a diagnosis of AD, with no evidence of non-AD disease to account for dementia or MRI exclusion criteria
- Medications taken for symptomatic treatment of AD must remain stable for at least 30 days prior to screening visit
- 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)
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: [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.
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Participants will receive [18F]GTP1 as per the schedule specified in the arm description.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change in Standardized Uptake Value Ratio (SUVR) as Measured by [18F]GTP1
Time Frame: From Baseline to 18 months
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From Baseline to 18 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)13
Time Frame: From Baseline to 18 months
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From Baseline to 18 months
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Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Volumetric Magnetic Resonance Imaging (MRI) Measures
Time Frame: From Baseline to 18 months
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From Baseline to 18 months
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Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Cerebrospinal Fluid (CSF) Markers
Time Frame: From Baseline to 18 months
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From Baseline to 18 months
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Percentage of Participants With Adverse Events (AEs)
Time Frame: From Baseline to 18 months
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From Baseline to 18 months
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Test-Retest Variability Based on [18F]GTP1 PET Scans
Time Frame: From date of test scan to 7-21 days after test scan
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From date of test scan to 7-21 days after test scan
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GN30009
- G0097 (Other Identifier: InVicro)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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