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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 : Recruiting
First Posted : December 28, 2015
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 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 : January 11, 2018
Estimated Study Completion Date : January 11, 2018


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



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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
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

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

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)

Information from the National Library of Medicine

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


Contacts
Contact: Reference Study ID Number: GN30009 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
United States, Connecticut
University of Connecticut Health Center; Department of Medicine Not yet recruiting
Farmington, Connecticut, United States, 06030
Molecular NeuroImaging Completed
New Haven, Connecticut, United States, 06510
KI Health Partners, LLC; New England Institute for Clinical Research Not yet recruiting
Stamford, Connecticut, United States, 06905
United States, District of Columbia
Georgetown University Hospital Not yet recruiting
Washington, District of Columbia, United States, 20057
United States, Florida
Neuropsychiatric Research; Center of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33912
Miami Jewish Health Systems Terminated
Miami, Florida, United States, 33137
Compass Research Recruiting
Orlando, Florida, United States, 32806
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30303
Atlanta Center For Medical Research Not yet recruiting
Atlanta, Georgia, United States, 30331
NeuroStudies.net, LLC Completed
Decatur, Georgia, United States, 30033
United States, Maine
Acadia Clinical Research; Dr. Henderson's Office Terminated
Bangor, Maine, United States, 04401
Maine Medical Center Not yet recruiting
Portland, Maine, United States, 04102
United States, Massachusetts
Beth Israel Deaconess Med Ctr; Neurology/MS Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Lahey Clinic Inc. - PARENT ACCOUNT Not yet recruiting
Burlington, Massachusetts, United States, 01805
Donald S. Marks, M.D., P.C.; Medical Center Recruiting
Plymouth, Massachusetts, United States, 02360
Alzheimers Disease Center Recruiting
Quincy, Massachusetts, United States, 02169
United States, New Jersey
NeuroCognitive Institute Recruiting
Mount Arlington, New Jersey, United States, 07856
Bio Behavioral Health Terminated
Toms River, New Jersey, United States, 08755
United States, New York
New York University Medical Center PRIME Not yet recruiting
New York, New York, United States, 10016
University of Rochester; Div. of Pediatric Pulmonology & Allergy Not yet recruiting
Rochester, New York, United States, 14642
United States, Ohio
Advanced Medical Research Terminated
Maumee, Ohio, United States, 43537
United States, Pennsylvania
Lehigh Center Clinical Research Terminated
Allentown, Pennsylvania, United States, 18104
United States, Rhode Island
Rhode Island Mood & Memory Research Institute Recruiting
East Providence, Rhode Island, United States, 02914
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02640092     History of Changes
Other Study ID Numbers: GN30009
G0097 ( Other Identifier: Molecular NeuroImaging )
First Posted: December 28, 2015    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

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