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RO6958948

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Roche Holding AG|Last Updated: Nov 1, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment4

FDA Designations

No designations recorded

Clinical trial landscape

RO6958948 · 1 trial · 1 indication

Phase 1 1
NCT02792179Evaluation of [18F]RO6958948 as Tracer for Positron Emission Tomography (PET) Imaging of Tau Burden in Alzheimer's Disease ParticipantsAlzheimer's Disease
COMPLETED4 Analytics
PHASE1COMPLETED
Evaluation of [18F]RO6958948 as Tracer for Positron Emission Tomography (PET) Imaging of Tau Burden in Alzheimer's Disease Participants
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Regional Standardized Uptake Value (SUV), as Assessed by the tau PET Brain Scan
Day 1
Regional Standardized Uptake Value Ratios (SUVR), as Assessed by the Tau PET Brain Scan
Day 1
Change in SUV for Different Brain Regions
Baseline to approximately 24 months
Change in SUVR for Different Brain Regions
Baseline to approximately 24 months

Secondary Endpoints

Percentage of Participants with Adverse Events
Screening to 7-14 days after Tau PET scan (Up to approximately 7 weeks)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
[18F]RO6958948EXPERIMENTALEach participant will receive a single intravenous (IV) dose of \[18F\]RO6958948 and a single PET scan approximately 9-24 months after the baseline scan (in Study BP29409).

Interventions

NameTypeDescription
[18F]RO6958948DRUGRadiolabeled low molecular weight compound, administered as single IV injection. The mass dose of \[18F\]RO6958948 injected will be less than or equal to (\</=) 10 micrograms (µg), injection volume \</=20 mL. Target injected activity for \[18F\]RO6958948 will be 370 megaBecquerel (MBq) (10 millicurie \[mCi\]).
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Eligibility Criteria

Age Range25 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * AD participants previously scanned with \[18F\]RO6958948 in Roche Study BP29409 * Agreement to use highly effective contraception measures * Body mass index (BMI) between 18 and 32 Kilograms per square meter (kg/m\^2) * A study partner able to accompany the participant to all ...

Countries:United States
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Frequently asked questions about RO6958948

What is RO6958948 used for in Alzheimer's Disease?

RO6958948 is an investigational small molecule being studied for use in Alzheimer's Disease. It was evaluated as a tracer for positron emission tomography (PET) imaging of tau burden in Alzheimer's Disease participants. The drug is in Phase 1 clinical development and is not approved for any use.

What does RO6958948 target?

RO6958948 is a tracer for positron emission tomography (PET) imaging of tau burden. It is designed to bind to tau protein aggregates in the brain, allowing visualization of tau pathology in Alzheimer's Disease. The drug's mechanism involves targeting tau, a protein that forms neurofibrillary tangles in Alzheimer's Disease.

Who makes RO6958948?

RO6958948 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational small molecule for Alzheimer's Disease. Roche is responsible for the development and potential commercialization of RO6958948.

What phase is RO6958948 in?

RO6958948 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was an uncontrolled, non-randomized, open-label study. The drug is investigational and has not been approved by regulatory authorities. It is still in early-stage clinical testing for Alzheimer's Disease.

What clinical trials is RO6958948 in?

RO6958948 has been studied in one clinical trial, NCT02792179, titled 'Evaluation of [18F]RO6958948 as Tracer for Positron Emission Tomography (PET) Imaging of Tau Burden in Alzheimer's Disease Participants.' This Phase 1 trial was completed in the United States with 4 participants. The trial was uncontrolled and not blinded.

Is RO6958948 the same as [18F]RO6958948?

Yes, RO6958948 is the same as [18F]RO6958948. The [18F] designation indicates that the molecule is labeled with the radioactive isotope fluorine-18, which enables its use as a PET imaging tracer. The clinical trial NCT02792179 specifically evaluated [18F]RO6958948 for imaging tau burden in Alzheimer's Disease.