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RO6958948

Phase 1

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

RO6958948 target and mechanism

ModalitySmall molecule

Also known as [18F]RO6958948

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment4

FDA Designations

No designations recorded

RO6958948 clinical trials

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?

RO6958948 is an investigational small molecule developed by Roche Holding AG as a PET imaging tracer for evaluating tau burden in Alzheimer's disease. It is also known as [18F]RO6958948. It is designed for use in positron emission tomography imaging rather than as a therapeutic treatment, and it remains in clinical development.

What is RO6958948 used for in Alzheimer's disease?

RO6958948 is used as a tracer for positron emission tomography imaging of tau burden in participants with Alzheimer's disease. Its purpose is to help visualize and evaluate tau accumulation in the brain during PET scans. It is an imaging agent, not a treatment intended to modify the course of Alzheimer's disease.

Who makes RO6958948?

RO6958948 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating this imaging tracer. The compound is also referred to as [18F]RO6958948 in study documentation and scientific literature.

What phase is RO6958948 in?

RO6958948 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The program includes one completed Phase 1 trial, and no active trials are currently listed. The completed study enrolled four participants and was conducted in the United States.

What clinical trials is RO6958948 in?

RO6958948 has been studied in one Phase 1 trial, NCT02792179, titled Evaluation of [18F]RO6958948 as Tracer for Positron Emission Tomography (PET) Imaging of Tau Burden in Alzheimer's Disease Participants. The trial is completed, enrolled four participants, was uncontrolled, and was conducted in the United States in participants aged 25 years and older.

Is RO6958948 the same as [18F]RO6958948?

Yes, RO6958948 and [18F]RO6958948 refer to the same compound. The bracketed fluorine-18 notation indicates the radiolabeled form used as a positron emission tomography tracer. Both names appear in study documentation for the same Roche imaging agent being evaluated for tau burden in Alzheimer's disease.