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GTP1

Phase 1

Alzheimer Disease | Unknown | Neurology |Roche Holding AG|Last Updated: Jul 12, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

GTP1 · 3 trials · 3 indications

Phase 1 3
NCT04566003Evaluation 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 DiseaseAlzheimer Disease (AD)
COMPLETED40 Analytics
NCT04394845A Study of the Biodistribution and Safety of [18F]GTP1 in Healthy Japanese ParticipantsAlzheimer Disease
COMPLETED6 Analytics
NCT02640092Longitudinal Evaluation of [18F]GTP1 as a PET Radioligand for Imaging Tau in the Brain of Participants With Alzheimer's Disease Compared to Healthy ParticipantsAlzheimer's Disease
COMPLETED72 Analytics
PHASE1COMPLETED
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
Alzheimer Disease (AD)Unlock trial analytics
PHASE1COMPLETED
A Study of the Biodistribution and Safety of [18F]GTP1 in Healthy Japanese Participants
Alzheimer DiseaseUnlock trial analytics
PHASE1COMPLETED
Longitudinal Evaluation of [18F]GTP1 as a PET Radioligand for Imaging Tau in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants with Adverse Events (AEs)
Up to approximately 4 days after administration of each radiotracer
Brain tau burden as measured by [18F]PI-2620 - PET
Approximately 1 hour after injection of [18F]PI-2620
Brain tau burden as measured by [18F]GTP1 - PET
Approximately 1 hour after injection of [18F]PI-2620
Brain tau burden as measured by [18F]MK-6240 - PET
Approximately 1 hour after injection of [18F]MK-6240
Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
Day 1

Decay corrected \[18F\]GTP1 time-activity in the source organs acquired following bolus tracer injection and expressed as %Injected Dose (ID).

Source Organ Residence Time (Total Number of Disintegrations)
Day 1

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

Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Day 1

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

Percentage of Participants With Adverse Events
Up to 5 days

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.

Change in Standardized Uptake Value Ratio (SUVR) as Measured by [18F]GTP1
From Baseline to 18 months

Secondary Endpoints

Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)13
From Baseline to 18 months
Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Volumetric Magnetic Resonance Imaging (MRI) Measures
From Baseline to 18 months
Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Cerebrospinal Fluid (CSF) Markers
From Baseline to 18 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
[18F]PI-2620 PET, then [18F]GTP1 PETEXPERIMENTALParticipants 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-6240EXPERIMENTALParticipants 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]GTP1EXPERIMENTALParticipants will receive a single bolus injection of radioligand \[18F\]GTP1 intravenously (IV).

Interventions

NameTypeDescription
[18F]GTP1DRUGParticipants will receive a bolus IV of approximately 7mCi of \[18F\]GTP1 radiotracer.
[18F]PI-2620DRUGParticipants will receive a bolus IV of approximately 5mCi of \[18F\]PI-2620 radiotracer.
[18F]MK-6240DRUGParticipants will receive a bolus IV of approximately 5mCi of \[18F\]MK-6240 radiotracer.
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Eligibility Criteria

Age Range50 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:United States
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Frequently asked questions about GTP1

What is GTP1 used for in Alzheimer's Disease?

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.

What does GTP1 target?

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.

Who makes GTP1?

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.

What phase is GTP1 in?

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.

What clinical trials is GTP1 in?

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.

Is GTP1 the same as [18F]GTP1?

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.