The main objective of this study is to continue to collect long-term safety and tolerabilitydata in participants with AD treated with gantenerumab. Specific objectives andcorresponding endpoints for the study are outlined in Table 1 of the protocol…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
centraal zenuwstelsel aandoeningen, neurologische aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
There will be no formal confirmatory efficacy analyses for this study.
Secondary outcome
To monitor AD progression, MMSE will be summarized using mean, SD, median,
inter-quartile range and minimum and maximum. No hypothesis testing will be
performed.
Exploratory biomarker analyses will include MRI volumetric changes.
Background summary
Alzheimer's disease is the most common cause of dementia, leading to
progressive decline in cognitive functions, impaired functioning and loss of
independence. This disease is a major public health problem.
The deposition of amyloid plays an important role in the pathogenesis of
Alzheimer's disease. Gantenerumab is a human antibody directed against the
amyloid plaques present in the brains of patients with Alzheimer's disease.
The role of Gantenerumab in preventing / reducing plaques has been and is being
investigated in several studies. It may have a beneficial effect on this.
Previous studies have investigated doses up to 1200 mg, which show a positive
profile (WN25203 and WN28745.
It is also important to investigate the longer-term safety.
In view of the growing population of patients with AD disease and the impact
and consequences of this, there is a great need for improvement in the
treatment of AD disease.
Study objective
The main objective of this study is to continue to collect long-term safety and
tolerability
data in participants with AD treated with gantenerumab. Specific objectives and
corresponding endpoints for the study are outlined in Table 1 of the protocol
Study design
This is an open-label, multicenter, rollover study to evaluate the safety and
tolerability of long-term administration of gantenerumab in participants with
AD.
All participants who have completed the OLEs of Studies WN25203 or WN28745 will
be eligible to participate in this study.
Intervention
This study is an open-label study, and each participant enrolled will be
administered the same dose of gantenerumab that was received at the final
dosing visit of the previous parent study (OLE part of Studies WN25203 or
WN28745).
Participants who have a dose gap between the last visit from the
WN25203/WN28745 OLE and this study, depending on the actual duration of the
dosing gap and their ARIA-E history, may be asked to start with a lower dose,
as detailed in Appendix 3 of the protocol.
Study burden and risks
The following procedures are performed:
Physical examination, measurement of vital signs, ECG, MRI, blood tests, sc
injections of research drug, pregnancy test and questionnaires.
There is a chance of (un) known side effects of Gantenerumab or the procedures.
These are listed in the IB V15 Gantenerumab and in the ICF. Risks are carefully
monitored during the study (MRI, ECG, vital signs, (S) AEs, blood collection)
to ensure the safety of the test subjects.
Beneluxlaan 2a
Woerden 3446 GR
NL
Beneluxlaan 2a
Woerden 3446 GR
NL
Listed location countries
Age
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) were eligible to participate Part 1 of the study
- For women of childbearing potential: agreement to remain abstinent 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 will be
needed for all participants
- Availability of a person (referred to as the "caregiver" throughout this
protocol) 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 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
- Evidence of intracerebral macrohemorrhage
Eligibility in Part 2
- All participants who have completed Week 104 visit in Part 1 of the study
and have not been discontinued from Part 1 of the study can continue to
participate in Part 2 of the study
- The inclusion and exclusion criteria mentioned above are also applicable for
Part 2 of the study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-004431-23-NL |
| CCMO | NL72531.056.20 |