Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [18F]GTP1
GTP1 · 3 trials · 3 indications
Decay corrected \[18F\]GTP1 time-activity in the source organs acquired following bolus tracer injection and expressed as %Injected Dose (ID).
Source organ uptake and washout with calculation of total number of disintegrations (or residence time, or kinetic values) using the area under the time-activity curve divided by the injected dose of radiopharmaceutical
Radiation absorbed dose estimates based on the Medical Internal Radiation Dose (MIRD) methodology utilizing urine data and International Commission on Radiological Protection (ICRP) gastrointestinal (GI) tract kinetics
An AE is the appearance or worsening of any undesirable sign, symptom, or medical condition, even if the event is not considered to be related to study drug. Study drug includes the investigational drug under evaluation during any phase of the study. Medical conditions/diseases present before starting study drug are only considered AEs if they worsen after starting study drug. Abnormal laboratory values or test results constitute AEs only if they induce clinical signs or symptoms, are considered clinically significant, or require therapy.
| Arm | Type | Description |
|---|---|---|
| [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. |
| [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. |
| [18F]GTP1 | EXPERIMENTAL | Participants will receive a single bolus injection of radioligand \[18F\]GTP1 intravenously (IV). |
| Name | Type | Description |
|---|---|---|
| [18F]GTP1 | DRUG | Participants will receive a bolus IV of approximately 7mCi of \[18F\]GTP1 radiotracer. |
| [18F]PI-2620 | DRUG | Participants will receive a bolus IV of approximately 5mCi of \[18F\]PI-2620 radiotracer. |
| [18F]MK-6240 | DRUG | Participants will receive a bolus IV of approximately 5mCi of \[18F\]MK-6240 radiotracer. |
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 mil...
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GTP1, also known as [18F]GTP1, is an investigational small molecule PET radiotracer developed by Roche Holding AG (ticker RHHBY) for imaging tau protein in the brain. It is being studied in Alzheimer disease and related research settings as a diagnostic imaging agent rather than as a treatment.
GTP1 is used as a PET imaging radioligand to visualize and quantify tau accumulation in the brains of people with Alzheimer disease. Trials have compared it with other tau PET tracers and evaluated it in participants ranging from normal cognition to moderate Alzheimer disease.
GTP1 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche has sponsored the clinical studies evaluating [18F]GTP1 as a tau PET radioligand, including trials conducted in the United States.
GTP1 is in Phase 1 clinical development. All three of its recorded trials are Phase 1 studies, and all three have been completed. It is an investigational imaging agent and is not described as approved for commercial use.
GTP1 has been studied in three completed Phase 1 trials: NCT04566003, which compared tau PET radiotracers including [18F]GTP1 and [18F]PI-2620 or [18F]MK-6240; NCT04394845, a biodistribution and safety study in healthy Japanese participants; and NCT02640092, a longitudinal tau imaging study in Alzheimer disease.
Yes, GTP1 and [18F]GTP1 refer to the same compound. [18F]GTP1 is the radiolabeled form of the tracer, with fluorine-18 attached for PET imaging, and both names appear in the clinical trial literature for this Roche tau imaging agent.