A long-term extension study to evaluate the safety, tolerability, and efficacy of AL002 in participants with early Alzheimer's disease
Study Information
This is an Phase II - Extension study.
Only participants who have successfully completed the previous Phase II study with AL002 can be enrolled (INVOKE-2 study).
Information about the drug that will be tested in the study
Administration
The drug will be administered via an intravenous infusion (an injection into the vein) every four weeks.
Is the drug already on the market for another medical condition?
No
Will all participants receive the same drug?
All participants will receive intravenous infusions of AL002. Three doses of AL002 will be tested.
Information about participating in the trial
What are the researchers trying to find out?
The purpose of the study is to evaluate the long-term safety and efficacy of AL002 in people with early Alzheimer's disease.
How long will the treatment last?
Around 1 year
What your involvement will entail?
- During the study, participants will be asked to complete some laboratory tests to evaluate the emergent adverse effects (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study)
- Participants will be asked to undertake brain scans (MRI).
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Be 50 to 85 years old
- Have completed the planned treatment period in the AL002-2 study
- Be willing and able to give informed consent
- Have a study partner who has a sufficient contact with the participant and is willing to participate in study procedures throughout the study duration (at least 10 hours a week).
Who cannot participate in the study?
Exclusion criteria include:
- Participants deemed not able to provide consent or assent by the Investigator or by local regulations
- Participants who were prematurely and permanently discontinued from treatment in the AL002-2 study for safety reasons
- Participation deemed inappropriate per Investigator discretion.
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
EudraCT Number
2022-002987-57
Clinicaltrials.gov identifier
NCT05744401
Study contact information
Link to full text
https://clinicaltrials.gov/study/NCT05744401
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on January 2024.
This document has been reviewed by the pharmaceutical company running this trial.
