Long-term extension of Phase 3 study of ALZ- 801 in APOE4/4 early AD subjects
This study is an extension study.
Information about the drug that will be tested in the study
Administration
Oral tablet twice daily (in the morning and in the evening)
Is the drug already on the market for another medical condition?
No
Will all participants receive the same drug?
All participants will receive ALZ-801. They will start with one tablet (265mg) in the evening during the first 4 weeks and they will then take one tablet (265mg) twice a day.
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 ALZ-801 in people with early Alzheimer's disease with the APOE4/4 genotype.
How long will the treatment last?
- Participants will be treated for 52 weeks
- Followed by a 4-week safety follow-up visit.
What your involvement will entail?
- During the study, participants will be asked to complete tests that will assess their functioning, behaviour, quality of life and memory (i.e. ADAS-Cog, MMSE, CDR)
- 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)
- During the study, participants will have to undergo brain scan (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 between 50 and 85 years old
- Have completed the week 78 of the Phase 3 core study (APOLLOE4)
- Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration and report on cognitive and functional abilities.
Who cannot participate in the study?
People cannot take part in the study if they have or have experienced:
- Significant worsening of medical conditions that may preclude completion of this study
- Evidence of moderate-severe side-effects
- Has received (or plans to receive) amyloid antibodies since completing Phase 3 core study (APOLLOE4).
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
Clinicaltrials.gov identifier
NCT06304883
Study contact information
clinicaltrialsinfo@alzheon.com
Link to full text
https://clinicaltrials.gov/study/NCT06304883
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on December 2024.
This document has been reviewed by a member of the European Working Group of People with Dementia.
This document has been reviewed by the pharmaceutical company running this trial.
