At a glance
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A Phase 1b Dose Range Finding Study of Phenserine Compared to Donepezil in Participants With Early or Mild Alzheimer's Disease
In Brief
A Phase 1 clinical trial evaluating Phenserine and Donepezil (Aricept®) for Alzheimer Disease and Mild Cognitive Impairment. Completed, enrolled 16 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Phenserine is a next generation AChE inhibitor being developed for the treatment of AD. Unlike currently marketed AChE inhibitors, it has additional mechanisms of action that also include a mediating effect on cell death pathways and anti-amyloid activity, which may confer disease-modifying effects in people with AD. Phenserine was originally identified and developed by the United States (U.S.) National Institute of Aging (NIA), part of the U.S National Institute of Health (NIH). The study intervention will be open label. No blinding will be performed. Participants and site staff will, however, will be blinded to the results of the exosome and blood/CSF biomarker evaluations until the study is completed.
The substance donepezil (under the brand name Aricept®) is a resale product. No additional manufacturing or labeling measures is necessary for this study. The NIMP, donepezil will be available in 5 mg and 10 mg strengths (table 3) and will be dispensed by the local pharmacy at the hospital where the participant in the donepezil arm is included. We have based the use of donepezil as a treatment in the study on the original product from Pfizer, but it is also possible to use generic products of donepezil if this is what the local pharmacy has for dispensing. Participants randomized to treatment with donepezil will follow the treatment plan according to the patient information leaflet. . These tablets are approved for clinical use and comply with all relevant safety and efficacy standards.