Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 is an investigational PET radioligand being studied for imaging tau protein in the brain of people with Alzheimer's Disease. It is being evaluated in Phase 1 clinical trials to assess its safety, biodistribution, and ability to visualize tau pathology compared to healthy participants.
GTP1 targets tau protein in the brain. It is a PET radioligand designed to bind to tau aggregates, which are a hallmark of Alzheimer's Disease, allowing visualization of tau pathology through positron emission tomography imaging.
GTP1 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting Phase 1 clinical trials to evaluate the radioligand for imaging tau in Alzheimer's Disease.
GTP1 is in Phase 1 clinical development. It is an investigational PET radioligand, not yet approved, and is being studied for imaging tau in Alzheimer's Disease. All three known trials have been completed.
GTP1 has been studied in three completed Phase 1 trials: NCT02640092, which evaluated [18F]GTP1 for imaging tau in Alzheimer's Disease versus healthy participants; NCT04394845, a biodistribution and safety study in healthy Japanese participants; and NCT04566003, comparing GTP1 with other tau PET radiotracers.
Yes, GTP1 is also known as [18F]GTP1, which is the radiolabeled form used in PET imaging. Clinical trial titles refer to [18F]GTP1, indicating the fluorine-18 labeled version of the compound.