Phenserine on the Alzheimer's Treatment Horizon, Study 1
Status:
NOT_YET_RECRUITING
Trial end date:
2028-01-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to evaluate if phenserine can treat early or mild Alzheimer's Disease (AD) by comparing it to donepezil. This study will include participants with early or mild Alzheimer's Disease, and the main questions it aims to answer are:
How does phenserine affect exosome biomarkers of cell death compared to donepezil? What is the safety and tolerability profile of phenserine at ascending oral doses compared to donepezil? Researchers will compare participants receiving phenserine to those receiving donepezil to see if phenserine produces better pharmacodynamic outcomes and if it is safe and well-tolerated.
Participants will:
Be randomized to receive either oral phenserine or oral donepezil for a treatment duration of 8 weeks.
Undergo oral dose escalation based on tolerability. Complete regular follow-up visits every two weeks to assess pharmacodynamic, pharmacokinetic, and safety measures.
Phase:
PHASE1
Details
Lead Sponsor:
Helse Stavanger HF
Collaborators:
Helse Fonna National Institutes of Health (NIH) St. Olavs Hospital University Hospital of North Norway University of Exeter