Evaluation Comparing Tau PET Radiotracers, [18F]GTP1 and [18F]PI-2620 or [18F]MK-6240 in Subjects With Normal Cognition or Prodromal to Moderate Alzheimer's Disease
Primary Purpose
Alzheimer Disease (AD)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]GTP1
[18F]PI-2620
[18F]MK-6240
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer Disease (AD)
Eligibility Criteria
Inclusion Criteria
- Cognitively normal subjects aged 65 to 90 years and prodromal to mild AD subjects aged 50 to 90 years, inclusive at the time of screening.
- Prodromal to moderate AD subjects: Meet the National Institute on Aging - Alzheimer's Association (NIA-AA) core clinical criteria for mild cognitive impairment (MCI) due to AD, probable AD dementia or AD dementia
- Have a Clinical Dementia Rating (CDR) score of 0 (cognitively normal) or 0.5 (prodromal to moderate AD) at screening
- Have an Mini-Mental State Examination (MMSE) score 10-30 inclusive
- Have Aβ PET imaging demonstrating Aβ binding based on qualitative visual read at screening or using an acceptable historical PET scan (cognitively normal subjects will be assessed with Aβ PET at screening but will not be required to demonstrate Aβ binding).
- A brain MRI consistent with normal cognition or that supports a diagnosis of prodromal to moderate AD, with no evidence of other significant neurologic pathology. A previously acquired research MRI within the last 12 months may be used if deemed acceptable by the investigator and no significant clinically relevant changes have occurred since the prior MRI was obtained
- The subject has an appropriate study partner capable of participating in CDR assessment and, if necessary, of accompanying the subject
- For cognitively normal subjects only: History of at least one first degree relative with diagnosis of Alzheimer's disease (self-reported by the potential subject and/or confirmed by the study partner).
Exclusion Criteria
- Current or prior history of any alcohol or drug abuse within the last 2 years
- Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 millisievert (mSv), which would be above the acceptable annual limit established by the US Federal Guidelines
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease
- MRI evidence of cerebrovascular disease, infectious disease, space-occupying lesions, normal pressure hydrocephalus, or other central nervous system (CNS) disease
- Implants that have not been certified for MRI or history of claustrophobia in MRI, unless an acceptable previously acquired research MRI is available
Sites / Locations
- Invicro, a Konica Minolta company
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
[18F]PI-2620 PET, then [18F]GTP1 PET
[18F]GTP1 PET, then [18F]MK-6240
Arm Description
Participants will undergo one [18F]PI-2620 PET imaging session, then one [18F]GTP1 PET imaging session. Prior to each session, participants will be administered a bolus intravenous injection of approximately 5 millicurie (mCi) of [18F]PI-2620 or 7mCi of [18F]GTP1.
Participants will undergo one [18F]GTP1 PET imaging session, then one [18F]MK-6240 PET imaging session. Prior to each session, participants will be administered a bolus intravenous injection of approximately 5 millicurie (mCi) of [18 F]MK-6240 or 7mCi of [18F]GTP1.
Outcomes
Primary Outcome Measures
Percentage of Participants with Adverse Events (AEs)
Brain tau burden as measured by [18F]PI-2620 - PET
Brain tau burden as measured by [18F]GTP1 - PET
Brain tau burden as measured by [18F]MK-6240 - PET
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04566003
Brief Title
Evaluation Comparing Tau PET Radiotracers, [18F]GTP1 and [18F]PI-2620 or [18F]MK-6240 in Subjects With Normal Cognition or Prodromal to Moderate Alzheimer's Disease
Official Title
Phase 1 Evaluation Comparing Tau PET Radiotracers, [18F]GTP1 and [18F]PI-2620 or [18F]MK-6240 in Subjects With Normal Cognition or Prodromal to Moderate Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
June 27, 2023 (Actual)
Study Completion Date
June 27, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study aims to compare tau targeted radiotracers [18F]GTP1 and [18F]PI-2620 or [18F]MK-6240 in subjects with normal cognition or prodromal to moderate Alzheimer's disease (AD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease (AD)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[18F]PI-2620 PET, then [18F]GTP1 PET
Arm Type
Experimental
Arm Description
Participants will undergo one [18F]PI-2620 PET imaging session, then one [18F]GTP1 PET imaging session. Prior to each session, participants will be administered a bolus intravenous injection of approximately 5 millicurie (mCi) of [18F]PI-2620 or 7mCi of [18F]GTP1.
Arm Title
[18F]GTP1 PET, then [18F]MK-6240
Arm Type
Experimental
Arm Description
Participants will undergo one [18F]GTP1 PET imaging session, then one [18F]MK-6240 PET imaging session. Prior to each session, participants will be administered a bolus intravenous injection of approximately 5 millicurie (mCi) of [18 F]MK-6240 or 7mCi of [18F]GTP1.
Intervention Type
Drug
Intervention Name(s)
[18F]GTP1
Intervention Description
Participants will receive a bolus IV of approximately 7mCi of [18F]GTP1 radiotracer.
Intervention Type
Drug
Intervention Name(s)
[18F]PI-2620
Intervention Description
Participants will receive a bolus IV of approximately 5mCi of [18F]PI-2620 radiotracer.
Intervention Type
Drug
Intervention Name(s)
[18F]MK-6240
Intervention Description
Participants will receive a bolus IV of approximately 5mCi of [18F]MK-6240 radiotracer.
Primary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events (AEs)
Time Frame
Up to approximately 4 days after administration of each radiotracer
Title
Brain tau burden as measured by [18F]PI-2620 - PET
Time Frame
Approximately 1 hour after injection of [18F]PI-2620
Title
Brain tau burden as measured by [18F]GTP1 - PET
Time Frame
Approximately 1 hour after injection of [18F]PI-2620
Title
Brain tau burden as measured by [18F]MK-6240 - PET
Time Frame
Approximately 1 hour after injection of [18F]MK-6240
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Cognitively normal subjects aged 65 to 90 years and prodromal to mild AD subjects aged 50 to 90 years, inclusive at the time of screening.
Prodromal to moderate AD subjects: Meet the National Institute on Aging - Alzheimer's Association (NIA-AA) core clinical criteria for mild cognitive impairment (MCI) due to AD, probable AD dementia or AD dementia
Have a Clinical Dementia Rating (CDR) score of 0 (cognitively normal) or 0.5 (prodromal to moderate AD) at screening
Have an Mini-Mental State Examination (MMSE) score 10-30 inclusive
Have Aβ PET imaging demonstrating Aβ binding based on qualitative visual read at screening or using an acceptable historical PET scan (cognitively normal subjects will be assessed with Aβ PET at screening but will not be required to demonstrate Aβ binding).
A brain MRI consistent with normal cognition or that supports a diagnosis of prodromal to moderate AD, with no evidence of other significant neurologic pathology. A previously acquired research MRI within the last 12 months may be used if deemed acceptable by the investigator and no significant clinically relevant changes have occurred since the prior MRI was obtained
The subject has an appropriate study partner capable of participating in CDR assessment and, if necessary, of accompanying the subject
For cognitively normal subjects only: History of at least one first degree relative with diagnosis of Alzheimer's disease (self-reported by the potential subject and/or confirmed by the study partner).
Exclusion Criteria
Current or prior history of any alcohol or drug abuse within the last 2 years
Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 millisievert (mSv), which would be above the acceptable annual limit established by the US Federal Guidelines
Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease
MRI evidence of cerebrovascular disease, infectious disease, space-occupying lesions, normal pressure hydrocephalus, or other central nervous system (CNS) disease
Implants that have not been certified for MRI or history of claustrophobia in MRI, unless an acceptable previously acquired research MRI is available
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Invicro, a Konica Minolta company
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Learn more about this trial
Evaluation Comparing Tau PET Radiotracers, [18F]GTP1 and [18F]PI-2620 or [18F]MK-6240 in Subjects With Normal Cognition or Prodromal to Moderate Alzheimer's Disease
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