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Crenezumab dose level 1

Phase 1

Alzheimer Disease | Small molecule | Neurology |Roche Holding AG|Last Updated: Jul 24, 2019

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment77

FDA Designations

No designations recorded

Clinical trial landscape

Crenezumab dose level 1 · 1 trial · 1 indication

Phase 1 1
NCT02353598A Study of Crenezumab in Participants With Mild to Moderate Alzheimer DiseaseAlzheimer Disease
COMPLETED77 Analytics
PHASE1COMPLETED
A Study of Crenezumab in Participants With Mild to Moderate Alzheimer Disease
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with anti-crenezumab antibodies
From baseline up to follow-up period (Week 69)
Number of participants with suicidal ideation, suicidal behavior, and self-injurious behavior without suicidal intent, as determined using the columbia-cuicide severity rating scale (C-SSRS)
From baseline up to follow-up period (Week 69)
Number of participants with changes from baseline in vital signs, electrocardiogram (ECG) and clinical laboratory results
From baseline up to follow-up period (Week 69)
Number of participants with amyloid-related imaging abnormalities-hemorrhage (ARIA-H)
Up to Week 13
Number of participants with adverse events (AEs) and serious adverse events (SAEs) according to national cancer institute common terminology criteria for adverse events, version 4.0 (NCICTCAE v4.0)
From baseline up to follow-up period (Week 69)
Number of participants with of non-serious AEs of special interest
From baseline up to follow-up period (Week 69)
Number of participants with amyloid-related imaging abnormalities-edema/effusion (ARIA-E)
Up to Week 13

Secondary Endpoints

Serum concentration of crenezumab
Pre-dose on Day 1, 60-90 minutes (min) post infusion on Day 1, Days 2, 8, Week 2, pre-dose and 60-90 min post infusion on dosing day of Weeks 5, 9, 13, and 21; pre-dose and 60-90 min post infusion on dosing day of Weeks 25, 53, 61, and 69
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Double-blind treatment window: Crenezumab dose level 1EXPERIMENTALParticipants will recieve crenezumab dose level 1 once every 4 weeks.
Double-blind treatment window: Crenezumab dose level 2EXPERIMENTALParticipants will receive crenezumab dose level 2 once every 4 weeks.
Double-blind treatment window: Crenezumab dose level 3EXPERIMENTALParticipants will receive crenezumab dose level 3 once every 4 weeks.
Double-blind treatment window: PlaceboPLACEBO_COMPARATORParticipants will receive placebo matched to crenezumab once every 4 weeks.
Optional OLE window: CrenezumabEXPERIMENTALParticipants will receive crenezumab dose levels 1 2, or 3 once in every 4 weeks.

Interventions

NameTypeDescription
Crenezumab dose level 1DRUGParticipants will receive crenezumb dose level 1 IV infusion once every 4 weeks up to Week 13 in double-blind treatment window or up to Week 61 in optional OLE window.
Crenezumab dose level 2DRUGParticipants will receive crenezumb dose level 2 IV infusion once every 4 weeks up to Week 13 in double-blind treatment window or up to Week 61 in optional OLE window.
Crenezumb dose level 3DRUGParticipants will receive crenezumb dose level 3 IV infusion once every 4 weeks upto Week 13 in double-blind treatment window or up to Week 61 in optional OLE window.
PlaceboDRUGParticipants will receive placebo matched to crenezumab IV infusion once every 4 weeks upto Week 13 in double-blind treatment window.
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Eligibility Criteria

Age Range50 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Body weight greater than or equal (\>/=) 45 kilograms (kg) and less than or equal (\</=) 120 kg * Ages 50-90 years, inclusive * Availability of a person ("caregiver") who, in the investigator's judgment, has frequent and sufficient contact with the participant and is able to p...

Countries:United States
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Frequently asked questions about Crenezumab dose level 1

What is Crenezumab dose level 1 used for in Alzheimer Disease?

Crenezumab dose level 1 is an investigational small molecule being studied for the treatment of Alzheimer Disease. It is currently in Phase 1 clinical development. The drug is being evaluated in patients with mild to moderate Alzheimer Disease, as part of a placebo-controlled, double-blind, randomized trial.

What does Crenezumab dose level 1 target?

Crenezumab dose level 1 targets amyloid beta, a protein that forms plaques in the brains of people with Alzheimer Disease. By binding to amyloid beta, the drug aims to reduce plaque accumulation and potentially slow disease progression. This mechanism is being investigated in clinical trials.

Who makes Crenezumab dose level 1?

Crenezumab dose level 1 is being developed by Roche Holding AG, a multinational healthcare company. Roche is conducting clinical trials to evaluate the safety and efficacy of this drug for Alzheimer Disease. The company's stock is traded under the ticker RHHBY.

What phase is Crenezumab dose level 1 in?

Crenezumab dose level 1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a completed Phase 1 trial involving 77 participants with mild to moderate Alzheimer Disease.

What clinical trials is Crenezumab dose level 1 in?

Crenezumab dose level 1 is associated with clinical trial NCT02353598, titled 'A Study of Crenezumab in Participants With Mild to Moderate Alzheimer Disease'. This Phase 1 trial was conducted in the United States and has been completed. The study enrolled 77 participants and was randomized, double-blind, and placebo-controlled.

Is Crenezumab dose level 1 the same as Crenezumab?

Crenezumab dose level 1 is a specific dose level of the drug crenezumab. Crenezumab is being developed by Roche for Alzheimer Disease. The dose level 1 refers to a particular dosage being tested in clinical trials, while crenezumab is the broader drug name.