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Last Updated: September 28, 2022

CLINICAL TRIALS PROFILE FOR CRENEZUMAB


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Clinical Trials for Crenezumab

Trial ID Title Status Sponsor Phase Summary
NCT01723826 ↗ A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With Crenezumab Completed Genentech, Inc. Phase 2 This Phase II, open-label extension (OLE), multicenter study will evaluate the long-term safety and tolerability of crenezumab in participants with mild to moderate Alzheimer's disease who have participated in and completed the treatment period of the Phase II Study ABE4869g (NCT01343966) or ABE4955g (NCT01397578). Participants who received placebo in Study ABE4869g (NCT01343966) or ABE4955g (NCT01397578) will receive crenezumab. Anticipated time on study treatment is 144 weeks.
NCT01998841 ↗ A Study of Crenezumab Versus Placebo in Preclinical Presenilin1 (PSEN1) E280A Mutation Carriers to Evaluate Efficacy and Safety in the Treatment of Autosomal-Dominant Alzheimer's Disease (AD), Including a Placebo-Treated Non-Carrier Cohort Active, not recruiting Banner Alzheimer's Institute Phase 2 This study consists of 2 periods: [1] Study Period A - evaluating the efficacy and safety of Crenezumab versus Placebo in participants who carry the PSEN1 E280A autosomal-dominant mutation and do not meet the criteria for mild cognitive impairment due to AD or dementia due to AD and are thus, in a preclinical phase of AD. Participants will be randomised in a 1:1 ratio to receive either Crenezumab or Placebo subcutaneously (every 2 weeks) or intravenously (every 4 weeks) for at least 260 weeks. A cohort of participants (non-mutation carriers) will also be enrolled and will be dosed solely on Placebo and [2] Study Period B - Participants will be offered the opportunity to continue to receive study drug until the results of the study are known and post trial access to Crenezumab is started or development of Crenezumab is discontinued.
NCT01998841 ↗ A Study of Crenezumab Versus Placebo in Preclinical Presenilin1 (PSEN1) E280A Mutation Carriers to Evaluate Efficacy and Safety in the Treatment of Autosomal-Dominant Alzheimer's Disease (AD), Including a Placebo-Treated Non-Carrier Cohort Active, not recruiting National Institute on Aging (NIA) Phase 2 This study consists of 2 periods: [1] Study Period A - evaluating the efficacy and safety of Crenezumab versus Placebo in participants who carry the PSEN1 E280A autosomal-dominant mutation and do not meet the criteria for mild cognitive impairment due to AD or dementia due to AD and are thus, in a preclinical phase of AD. Participants will be randomised in a 1:1 ratio to receive either Crenezumab or Placebo subcutaneously (every 2 weeks) or intravenously (every 4 weeks) for at least 260 weeks. A cohort of participants (non-mutation carriers) will also be enrolled and will be dosed solely on Placebo and [2] Study Period B - Participants will be offered the opportunity to continue to receive study drug until the results of the study are known and post trial access to Crenezumab is started or development of Crenezumab is discontinued.
NCT01998841 ↗ A Study of Crenezumab Versus Placebo in Preclinical Presenilin1 (PSEN1) E280A Mutation Carriers to Evaluate Efficacy and Safety in the Treatment of Autosomal-Dominant Alzheimer's Disease (AD), Including a Placebo-Treated Non-Carrier Cohort Active, not recruiting Genentech, Inc. Phase 2 This study consists of 2 periods: [1] Study Period A - evaluating the efficacy and safety of Crenezumab versus Placebo in participants who carry the PSEN1 E280A autosomal-dominant mutation and do not meet the criteria for mild cognitive impairment due to AD or dementia due to AD and are thus, in a preclinical phase of AD. Participants will be randomised in a 1:1 ratio to receive either Crenezumab or Placebo subcutaneously (every 2 weeks) or intravenously (every 4 weeks) for at least 260 weeks. A cohort of participants (non-mutation carriers) will also be enrolled and will be dosed solely on Placebo and [2] Study Period B - Participants will be offered the opportunity to continue to receive study drug until the results of the study are known and post trial access to Crenezumab is started or development of Crenezumab is discontinued.
NCT02353598 ↗ A Study of Crenezumab in Participants With Mild to Moderate Alzheimer Disease Completed Genentech, Inc. Phase 1 This randomized, placebo-controlled, double-blind, parallel-arm study will evaluate the safety and tolerability of at least two dose levels of intravenous (IV) crenezumab in 24-72 participants with mild to moderate Alzheimer disease (AD) (mini-mental state examination [MMSE] 18 to 28 points, inclusive). An optional open-label extension (OLE) will be offered after the completion of initial double-blind stage.
NCT02427243 ↗ A Study in Healthy Volunteers to Assess the Relative Bioavailability and Tolerability of Two Crenezumab Formulations Following Administration of a Single Subcutaneous Dose Completed Genentech, Inc. Phase 1 To assess the relative bioavailability and tolerability of two different formulations of crenezumab in approximately 60 healthy volunteers.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Crenezumab

Condition Name

Condition Name for
Intervention Trials
Alzheimer's Disease 5
Alzheimer Disease 2
Healthy Volunteer 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Alzheimer Disease 7
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Clinical Trial Locations for Crenezumab

Trials by Country

Trials by Country for
Location Trials
United States 107
Spain 27
Italy 17
Canada 16
Australia 10
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Trials by US State

Trials by US State for
Location Trials
New York 5
Florida 5
California 5
Texas 5
Mississippi 5
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Clinical Trial Progress for Crenezumab

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 3
Phase 2 3
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Terminated 3
Completed 3
Recruiting 1
[disabled in preview] 1
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Clinical Trial Sponsors for Crenezumab

Sponsor Name

Sponsor Name for
Sponsor Trials
Genentech, Inc. 5
Hoffmann-La Roche 4
Banner Alzheimer's Institute 2
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 9
Other 2
NIH 2
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Colorcon
Baxter
Moodys
Medtronic

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