WN41874 - Gantenerumab Open Label Extension Study

Phase 1

• Conditions: Alzheimer's disease (AD); MedDRA version: 20.0Level: HLTClassification code 10001897Term: Alzheimer's disease (incl subtypes)System Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-004431-23-GB
• Lead Sponsor: F Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-19
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

All participants who completed the OLEs of Studies WN25203 or WN28745 (i.e., latest version of protocol in their countries, and did not discontinue study drug early) are eligible to participate in this study.

Eligible participants must provide written consent signed by them or by the participant’s legally authorized representative before his or her participation in the study

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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

Participants who meet any of the following criteria will not be eligible for this study:

- Prematurely discontinued from the OLEs of Studies WN25203 or WN28745 or from study
drug for any reason
- Any medical condition that the investigator or Sponsor determines 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, by determination of the investigator or Sponsor
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified