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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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ClinicalTrials.gov Identifier: NCT04566003
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : May 16, 2023
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Alzheimer Disease (AD) Drug: [18F]GTP1 Drug: [18F]PI-2620 Drug: [18F]MK-6240 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : October 26, 2020
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: [18F]PI-2620 PET, then [18F]GTP1 PET
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.
 Drug: [18F]GTP1
Participants will receive a bolus IV of approximately 7mCi of [18F]GTP1 radiotracer.

Drug: [18F]PI-2620
Participants will receive a bolus IV of approximately 5mCi of [18F]PI-2620 radiotracer.
Experimental: [18F]GTP1 PET, then [18F]MK-6240
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.
 Drug: [18F]GTP1
Participants will receive a bolus IV of approximately 7mCi of [18F]GTP1 radiotracer.

Drug: [18F]MK-6240
Participants will receive a bolus IV of approximately 5mCi of [18F]MK-6240 radiotracer.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 4 days after administration of each radiotracer ]
  2. Brain tau burden as measured by [18F]PI-2620 - PET [ Time Frame: Approximately 1 hour after injection of [18F]PI-2620 ]
  3. Brain tau burden as measured by [18F]GTP1 - PET [ Time Frame: Approximately 1 hour after injection of [18F]PI-2620 ]
  4. Brain tau burden as measured by [18F]MK-6240 - PET [ Time Frame: Approximately 1 hour after injection of [18F]MK-6240 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT04566003


Contacts
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Contact: Reference Study ID Number: GN42801 https://forpatients.roche.com/ 888-662-6728 global-roche-genentech-trials@gene.com

Locations
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United States, Connecticut
Invicro, a Konica Minolta company Recruiting
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04566003    
Other Study ID Numbers: GN42801
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: May 16, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders