Alzheimer Disease (AD)Phase 1NCT04566003
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
A Phase 1 study testing [18F]GTP1, [18F]PI-2620 and [18F]MK-6240 in people with Alzheimer Disease (AD), run by Genentech, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer Disease (AD)
- What is being tested?
- [18F]GTP1, [18F]PI-2620 and [18F]MK-6240
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2020to 27 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Invicro, a Konica Minolta company
New Haven, Connecticut, 06510
About this study
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
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).
- Conditions
- Alzheimer Disease (AD)
- Being tested
- [18F]GTP1, [18F]PI-2620, [18F]MK-6240
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]GTP1Drug
Participants will receive a bolus IV of approximately 7mCi of [18F]GTP1 radiotracer.
[18F]PI-2620Drug
Participants will receive a bolus IV of approximately 5mCi of [18F]PI-2620 radiotracer.
[18F]MK-6240Drug
Participants will receive a bolus IV of approximately 5mCi of [18F]MK-6240 radiotracer.
| Study group | Role | What they receive |
|---|---|---|
| [18F]PI-2620 PET, then [18F]GTP1 PET | Experimental | 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. Receives: Drug: [18F]GTP1; Drug: [18F]PI-2620 |
| [18F]GTP1 PET, then [18F]MK-6240 | Experimental | 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. Receives: Drug: [18F]GTP1; Drug: [18F]MK-6240 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events (AEs)
Measured: Up to approximately 4 days after administration of each radiotracer
Brain tau burden as measured by [18F]PI-2620 - PET
Measured: Approximately 1 hour after injection of [18F]PI-2620
Brain tau burden as measured by [18F]GTP1 - PET
Measured: Approximately 1 hour after injection of [18F]PI-2620
Brain tau burden as measured by [18F]MK-6240 - PET
Measured: Approximately 1 hour after injection of [18F]MK-6240
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start26 Oct 2020
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566003
- Sponsor's protocol ID
- GN42801
- Status last verified
- Jul 2023
- First submitted
- 22 Sep 2020
- Last updated
- 12 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04566003
- Acronym / sponsor ID
- GN42801
- Conditions
- Alzheimer Disease (AD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [18F]PI-2620 PET, then [18F]GTP1 PET | Experimental | Drug: [18F]GTP1, Drug: [18F]PI-2620Participants 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. |
| [18F]GTP1 PET, then [18F]MK-6240 | Experimental | Drug: [18F]GTP1, Drug: [18F]MK-6240Participants 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]GTP1Participants will receive a bolus IV of approximately 7mCi of [18F]GTP1 radiotracer. | Drug | [18F]GTP1 PET, then [18F]MK-6240, [18F]PI-2620 PET, then [18F]GTP1 PET |
| [18F]PI-2620Participants will receive a bolus IV of approximately 5mCi of [18F]PI-2620 radiotracer. | Drug | [18F]PI-2620 PET, then [18F]GTP1 PET |
| [18F]MK-6240Participants will receive a bolus IV of approximately 5mCi of [18F]MK-6240 radiotracer. | Drug | [18F]GTP1 PET, then [18F]MK-6240 |
Primary outcome
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 4 days after administration of each radiotracer
Brain tau burden as measured by [18F]PI-2620 - PET
Time frame: Approximately 1 hour after injection of [18F]PI-2620
Brain tau burden as measured by [18F]GTP1 - PET
Time frame: Approximately 1 hour after injection of [18F]PI-2620
Brain tau burden as measured by [18F]MK-6240 - PET
Time frame: Approximately 1 hour after injection of [18F]MK-6240
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]GTP1, [18F]PI-2620 and [18F]MK-6240 in people with Alzheimer Disease (AD), run by Genentech, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Adverse Events (AEs) (time frame: Up to approximately 4 days after administration of each radiotracer). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.