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
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ClinicalTrials.gov Identifier: NCT02640092 |
Recruitment Status :
Completed
First Posted : December 28, 2015
Last Update Posted : December 23, 2019
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer's Disease | Drug: [18F]GTP1 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | 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 |
Actual Study Start Date : | December 23, 2015 |
Actual Primary Completion Date : | June 11, 2019 |
Actual Study Completion Date : | June 11, 2019 |

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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Drug: [18F]GTP1
Participants will receive [18F]GTP1 as per the schedule specified in the arm description.
Other Names:
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- Change in Standardized Uptake Value Ratio (SUVR) as Measured by [18F]GTP1 [ Time Frame: From Baseline to 18 months ]
- 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 ]
- 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 ]
- 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 ]
- Percentage of Participants With Adverse Events (AEs) [ Time Frame: From Baseline to 18 months ]
- 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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Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640092
United States, Connecticut | |
Molecular NeuroImaging | |
New Haven, Connecticut, United States, 06510 | |
KI Health Partners, LLC; New England Institute for Clinical Research | |
Stamford, Connecticut, United States, 06905 | |
United States, Florida | |
Neuropsychiatric Research; Center of Southwest Florida | |
Fort Myers, Florida, United States, 33912 | |
Miami Jewish Health Systems | |
Miami, Florida, United States, 33137 | |
Bioclinica Research | |
Orlando, Florida, United States, 32806 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30303 | |
NeuroStudies.net, LLC | |
Decatur, Georgia, United States, 30033 | |
United States, Maine | |
Acadia Clinical Research; Dr. Henderson's Office | |
Bangor, Maine, United States, 04401 | |
United States, Massachusetts | |
Donald S. Marks, M.D., P.C.; Medical Center | |
Plymouth, Massachusetts, United States, 02360 | |
Alzheimers Disease Center | |
Quincy, Massachusetts, United States, 02169 | |
United States, New Jersey | |
NeuroCognitive Institute | |
Mount Arlington, New Jersey, United States, 07856 | |
Bio Behavioral Health | |
Toms River, New Jersey, United States, 08755 | |
United States, Ohio | |
Advanced Medical Research | |
Maumee, Ohio, United States, 43537 | |
United States, Pennsylvania | |
Lehigh Center Clinical Research | |
Allentown, Pennsylvania, United States, 18104 | |
United States, Rhode Island | |
Rhode Island Mood & Memory Research Institute | |
East Providence, Rhode Island, United States, 02914 | |
Butler Hospital | |
Providence, Rhode Island, United States, 02906 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT02640092 |
Other Study ID Numbers: |
GN30009 G0097 ( Other Identifier: InVicro ) |
First Posted: | December 28, 2015 Key Record Dates |
Last Update Posted: | December 23, 2019 |
Last Verified: | December 2019 |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |