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RO6924963

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Roche Holding AG|Trials Updated: Jan 2, 2019

RO6924963 target and mechanism

ModalitySmall molecule

Also known as [11C]RO6924963

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

RO6924963 clinical trials

RO6924963 · 1 trial · 1 indication

Phase 1 1
NCT02187627Evaluation of [11C]RO6924963, [11C]RO6931643, and [18F]RO6958948 as Tracers for Positron Emission Tomography (PET) Imaging of Tau in Healthy and Alzheimer's Disease (AD) ParticipantsAlzheimer's Disease, Healthy Volunteer
COMPLETED52 Analytics
PHASE1COMPLETED
Evaluation of [11C]RO6924963, [11C]RO6931643, and [18F]RO6958948 as Tracers for Positron Emission Tomography (PET) Imaging of Tau in Healthy and Alzheimer's Disease (AD) Participants
Alzheimer's Disease, Healthy VolunteerUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Standard Uptake Value (SUV), as Assessed by Tau PET Brain Scan
Day 1 up to Day 14
Part 1: Standard Uptake Value Ratio (SUVR), as Assessed by Tau PET Brain Scan
Day 1 up to Day 14
Part 1: SUV, as Assessed by Tau PET Scan of Whole Body
Day 1 up to Day 14
Part 1: SUVR, as Assessed by Tau PET Scan of Whole Body
Day 1 up to Day 14
Mean Residence Times for Each Organ, as Assessed by Tau PET Scan of Whole Body
Day 1 up to Day 14
Part 1: Distribution Volume (VT), as Assessed by Tau PET Brain Scan
Day 1 up to Day 14

Secondary Endpoints

Part 2A: Absolute Percentage Difference Between Test and Retest of SUVR
Days 1, 28
Part 2A: Absolute Percentage Difference Between Test and Retest of VT
Days 1, 28
Part 2B: Effective dose (ED), as Assessed by Whole Body PET Scan
From the time of tracer injection on Day 1 up to 120 minutes post injection
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part 1: Tracer SelectionEXPERIMENTALParticipants will receive a single dose of one tracer on one occasion and a single dose of a different tracer after 7 to 14 days and will be followed for 7 to 14 days for safety. At the end of Part 1, one tracer with the best performance will be selected for further study in Part 2.
Part 2A: Test-RetestEXPERIMENTALParticipants will receive a single dose of selected tracer from Part 1 on one occasion and then same tracer will be administered after 6 weeks. Participants will be followed for 7 to 14 days after last PET tracer administration for safety.
Part 2B: DosimetryEXPERIMENTALParticipants will receive a single dose of selected tracer from Part 1 and will be followed for 7 to 14 days for evaluation of radiation dosimetry.

Interventions

NameTypeDescription
[11C]RO6924963DRUGRadiolabeled low molecular weight compound, administered as single intravenous injection. The mass dose of \[11C\]RO6924963 injected will be \</=10 micrograms (mcg), injection volume \</=20 milliliters (mL). Target injected activity for \[11C\]RO6924963 will be 370-740 megabecquerel (MBq) \[10-20 millicurie (mCi)\].
[11C]RO6931643DRUGRadiolabeled low molecular weight compound, administered as single intravenous injection. The mass dose of \[11C\]RO6931643 injected will be \</=10 mcg, injection volume \</=20 mL. Target injected activity for \[11C\]RO6931643 will be 370-740 MBq (10-20 mCi).
[18F]RO6958948DRUGRadiolabeled low molecular weight compound, administered as single intravenous injection. The mass dose of \[18F\]RO6958948 injected will be \</=10 mcg, injection volume \</=20 mL. Target injected activity for \[18F\]RO6958948 will be 185-370 MBq (5-10 mCi). The final activity of \[18F\] RO6958948 will be adjusted up to 10 mCi per scan to allow sufficient counts by end of 200 minutes post radiotracer injection.
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Eligibility Criteria

Age Range25 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: Inclusion Criteria for All Participants * Agreement to use highly effective contraception measures * If participants are on any concomitant medication, the indication and dosage of these medicines should be stable for at least 4 weeks prior to study start with the expectation t...

Countries:United States
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Frequently asked questions about RO6924963

What is RO6924963?

RO6924963 is an investigational small molecule developed by Roche Holding AG as a positron emission tomography (PET) imaging tracer for tau protein in the brain. It was studied in Alzheimer's disease and healthy volunteers to evaluate its use as a tau imaging agent.

What is RO6924963 used for in Alzheimer's disease?

RO6924963 is being evaluated as a PET imaging tracer for detecting and measuring tau protein in the brains of people with Alzheimer's disease. It is intended as a diagnostic imaging tool rather than a therapeutic treatment for the disease.

Who makes RO6924963?

RO6924963 is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical research evaluating this compound as a tau PET imaging tracer.

What phase is RO6924963 in?

RO6924963 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The single Phase 1 trial evaluating it has been completed.

What clinical trials is RO6924963 in?

RO6924963 was evaluated in one completed Phase 1 trial, NCT02187627, titled Evaluation of [11C]RO6924963, [11C]RO6931643, and [18F]RO6958948 as Tracers for PET Imaging of Tau in Healthy and Alzheimer's Disease Participants. The trial enrolled 52 participants in the United States.

Is RO6924963 the same as [11C]RO6924963?

Yes, [11C]RO6924963 is another name for RO6924963. The [11C] prefix refers to the carbon-11 radiolabel used in the compound, which allows it to be detected during positron emission tomography imaging.