A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)

Phase 3TerminatedNCT04339413

Hoffmann-La Roche116 enrolled

Overview

The main purpose of the study was to evaluate the safety and tolerability of long-term administration of gantenerumab in participants with AD. All participants who have completed the open-label extensions (OLEs) of studies WN25203 or WN28745 were enrolled in Part 1 of this study. Of these, participants who completed Week 104 visit in Part 1. Participants received open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) at the same dose as administered in the parent studies (part 1)/ Week 104 visit.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

116

Conditions

Alzheimer Disease

Interventions

Gantenerumab

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Part 1: Participants who completed the open-label extensions (OLEs) of studies WN25203 or WN28745 will be eligible to participate in Part 1 of the study * Part 2: All participants who have completed Week 104 visit in Part 1 will be eligible for Part 2 of the study * For Part 1 and Part 2: * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 16 weeks after the last dose of study drug * Agreement to not donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug * Availability of a person ('caregiver') who in the investigator's judgement, has frequent and sufficient contact with the participant Exclusion Criteria: * Prematurely discontinued from the OLEs of studies WN25203 or WN28745 or from study drug for any reason * Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment * If the participant is unlikely to benefit from gantenerumab therapy, based on disease progression or other factors, or if study participation is otherwise not in the participant's best interest * Any investigational treatment other than gantenerumab during or since completion of the OLEs of studies WN25203 or WN28745 * Pregnancy * Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focal leptomeningeal hemosiderosis) * Evidence of intracerebral macrohemorrhage * Part 2: Participants who have been discontinued from Part 1 of the study

Locations (56)

Banner Sun Health Research Insitute

Sun City, Arizona, United States

California Neuroscience Research Medical Group, Inc

Sherman Oaks, California, United States

Accelerated Enrollment Solutions

Orlando, Florida, United States

University of South Florida

Tampa, Florida, United States

Bioclinica The Villages

The Villages, Florida, United States

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was defined as any untoward medical occurrence in a participant administered with gantenerumab and which does not necessarily have a causal relationship with gantenerumab. A Serious Adverse Event (SAE) is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above, and which does not necessarily have a causal relationship with gantenerumab.