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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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]GTP1
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Molecular NeuroImaging
  • KI Health Partners, LLC; New England Institute for Clinical Research
  • Neuropsychiatric Research; Center of Southwest Florida
  • Miami Jewish Health Systems
  • Bioclinica Research
  • Emory University
  • NeuroStudies.net, LLC
  • Acadia Clinical Research; Dr. Henderson's Office
  • Donald S. Marks, M.D., P.C.; Medical Center
  • Alzheimers Disease Center
  • NeuroCognitive Institute
  • Bio Behavioral Health
  • Advanced Medical Research
  • Lehigh Center Clinical Research
  • Rhode Island Mood & Memory Research Institute
  • Butler Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F]GTP1

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Standardized Uptake Value Ratio (SUVR) as Measured by [18F]GTP1

Secondary Outcome Measures

Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)13
Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Volumetric Magnetic Resonance Imaging (MRI) Measures
Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Cerebrospinal Fluid (CSF) Markers
Percentage of Participants With Adverse Events (AEs)
Test-Retest Variability Based on [18F]GTP1 PET Scans

Full Information

First Posted
December 15, 2015
Last Updated
December 19, 2019
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02640092
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 23, 2015 (Actual)
Primary Completion Date
June 11, 2019 (Actual)
Study Completion Date
June 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
[18F]GTP1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
[18F]GTP1
Other Intervention Name(s)
[18F]G02941054, [18F]MNI-798, [18F]RO6880276
Intervention Description
Participants will receive [18F]GTP1 as per the schedule specified in the arm description.
Primary Outcome Measure Information:
Title
Change in Standardized Uptake Value Ratio (SUVR) as Measured by [18F]GTP1
Time Frame
From Baseline to 18 months
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Percentage of Participants With Adverse Events (AEs)
Time Frame
From Baseline to 18 months
Title
Test-Retest Variability Based on [18F]GTP1 PET Scans
Time Frame
From date of test scan to 7-21 days after test scan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Molecular NeuroImaging
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
KI Health Partners, LLC; New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Neuropsychiatric Research; Center of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Miami Jewish Health Systems
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Bioclinica Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
NeuroStudies.net, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Acadia Clinical Research; Dr. Henderson's Office
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Donald S. Marks, M.D., P.C.; Medical Center
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
Country
United States
Facility Name
Alzheimers Disease Center
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
NeuroCognitive Institute
City
Mount Arlington
State/Province
New Jersey
ZIP/Postal Code
07856
Country
United States
Facility Name
Bio Behavioral Health
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Advanced Medical Research
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
Lehigh Center Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Rhode Island Mood & Memory Research Institute
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34852837
Citation
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.
Results Reference
derived
PubMed Identifier
31834365
Citation
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.
Results Reference
derived

Learn more about this trial

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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