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

A Double-Blind, Placebo-Controlled Parallel-Group Study in Preclinical PSEN1 E280A Mutation Carriers Randomized to Crenezumab or Placebo, and in Non-Randomized, Placebo-Treated Non-Carriers From the Same Kindred, to Evaluate the Efficacy and Safety of Crenezumab in the Treatment of Autosomal-Dominant Alzheimer's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Crenezumab	Crenezumab will be administered as per the schedule specified in the treatment arm.
DRUG	Placebo	Placebo will be administered as per the schedule specified in the treatment arm.

Timeline

• Start date: 2013-12-20
• Primary completion: 2022-03-22
• Completion: 2023-08-08
• First posted: 2013-12-02
• Last updated: 2024-07-30
• Results posted: 2023-09-22

Locations

4 sites across 1 country: Colombia