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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 : Active, not recruiting
First Posted : December 28, 2015
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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Brief Summary:
This is an open-label, longitudinal observational study evaluating the imaging characteristics of the tau positron-emission tomography (PET) radioligand [18F] Genentech Tau Probe 1 (GTP1) in the brain of participants with prodromal, mild, and moderate Alzheimer's disease (AD) compared to healthy participants. The overall goal of this protocol is to evaluate the longitudinal change in tau burden using [18F]GTP1, a tau targeted radiopharmaceutical.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: [18F]GTP1 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
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
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

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Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: [18F]GTP1
Participants will receive [18F]GTP1 as per the schedule specified in the arm description.
Other Names:
  • [18F]G02941054
  • [18F]MNI-798
  • [18F]RO6880276


Outcome Measures
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Primary Outcome Measures :
  1. Change in Standardized Uptake Value Ratio (SUVR) as Measured by [18F]GTP1 [ Time Frame: From Baseline to 18 months ]

Secondary Outcome Measures :
  1. Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Clinical Outcome [ Time Frame: From Baseline to 18 months ]
  2. 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 ]
  3. 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 ]
  4. Percentage of Participants With Adverse Events (AEs) [ Time Frame: From Baseline to 18 months ]
  5. Test-Retest Variability Based on [18F]GTP1 PET Scans [ Time Frame: From Baseline to 18 months ]

Eligibility Criteria
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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
Criteria

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)
Contacts and Locations
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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


Locations
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
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02640092     History of Changes
Other Study ID Numbers: GN30009
G0097 ( Other Identifier: InVicro )
First Posted: December 28, 2015    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders