Phenserine on the Alzheimer's Treatment Horizon, Study 1 (NCT06774261) | Clinical Trial Compass
CompletedPhase 1
Phenserine on the Alzheimer's Treatment Horizon, Study 1
Norway16 participantsStarted 2025-02-01
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* A diagnosis of AD based on the most recent NIA-AA diagnostic criteria for AD.
* A significant change on a validated AD amyloid or tau biomarker (as determined either by visual reading of amyloid PET scans \[using any of the approved ligands\], or CSF Aβ 1-42 or blood p-tau 217 levels \[cut-off as determined by the individual laboratory.
* A CDR Global rating of 0.5 or 1.0.
* An MRI scan within the past two years that has no findings inconsistent with AD.
* Participants who have recently participated in other clinical trials or have been under treatment with memantine or acetylcholinesterase inhibitors (e.g., Donepezil, Rivastigmine, Galantamine) must undergo a washout period of at least 4 weeks prior to the start of the study.
* Capacity to give informed consent based on the clinical judgement of an experienced clinician.
* The participant has an individual who is in regular, daily contact via phone or in-person visits and who can act as a reliable study partner and provide meaningful input into rating scales.
* Age ≥50 years.
* Fluency in Norwegian and evidence of adequate premorbid intellectual functioning.
* Capable of participating in all scheduled evaluations and complete all required tests.
* Female participants must be of non-childbearing potential or have a negative serum pregnancy test up to 24 hours prior to the baseline assessments and agree to use effective birth control throughout their participation in the study from signing informed conse…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was a Phase 1 study of Phenserine that has already completed — what does that mean in terms of how much is actually known yet about whether it is safe or beneficial for someone in my situation?
2The trial measured biomarkers related to cell death, synaptic integrity, inflammation, and Alzheimer's-specific markers in exosomes — can you help me understand what those biomarkers are and whether any results from this study have been published or shared that might be relevant to my care?
3Since this was an early-phase study focused on measuring biological signals rather than proving a treatment works, is there a follow-up Phase 2 or Phase 3 trial of Phenserine that might be worth considering, or is standard-of-care treatment a more proven path for me right now?
4Given that the study enrolled people with both Alzheimer's disease and mild cognitive impairment, does the stage I'm currently at match the kind of participants who were in this trial, and does that affect whether its findings are relevant to me?
5Are there any other trials or treatments targeting these same biological pathways — like neuroinflammation or synaptic loss — that might be appropriate for me to explore based on what this Phenserine study was measuring?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Panel 1: Concentration of Biomarkers Associated with Preprogrammed Cell Death (PNCDD)
Timeframe: From enrollment to the end of treatment at 8 weeks.
2
Panel 2: Concentration of Synaptic Integrity Biomarkers
Timeframe: From enrollment to the end of treatment at 8 weeks.
3
Panel 3: Concentration of TNF-α (Inflammatory Biomarker)
Timeframe: From enrollment to the end of treatment at 8 weeks.
4
Panel 3: Concentration of interleukins, IL-1β, IL-6, and IL-10. (Inflammatory Biomarker)
Timeframe: From enrollment to the end of treatment at 8 weeks.
5
Panel 4: Concentration of Exosome-Derived Alzheimer's Disease-Specific Biomarkers
Timeframe: From enrollment to the end of treatment at 8 weeks.