A PHASE 1B DOSE RANGE FINDING STUDY OF PHENSERINE COMPARED TO DONEPEZIL IN PARTICIPANTS WITH EARLY OR MILD ALZHEIMER’S DISEASE
This research study is investigating a new medication called phenserine for individuals living with early or mild Alzheimer's disease or mild cognitive impairment. It's a 'Phase 1B' study, which means it's an early step to find the right dose and see how safe it is. Researchers will compare phenserine to an existing Alzheimer's drug called donepezil (also known as Aricept®). The main goal is to understand how phenserine affects certain changes in the brain related to Alzheimer's, such as cell health, inflammation, and proteins. They will also look at side effects, how well the body handles the drug, and changes in memory and thinking abilities.
At a glance
What is this study about?
This study is exploring a new treatment called phenserine for people in the early stages of Alzheimer's disease or those with a condition called mild cognitive impairment. Alzheimer's disease affects memory and thinking, and researchers are always looking for new ways to help manage it. This study is an important early step (often called 'Phase 1B') to learn more about phenserine.
The main aim is to understand how different amounts, or 'doses,' of phenserine affect what's happening inside the brain. Scientists will look at specific tiny markers, called 'biomarkers,' in the blood that can tell them about things like brain cell health, inflammation, and how certain important proteins are moving around. They'll compare these effects in people taking phenserine with those taking a well-known Alzheimer's drug called donepezil (you might know it as Aricept®).
Beyond what's happening at a microscopic level, researchers will also carefully monitor the safety of phenserine. They will track any side effects, big or small, and check how well people tolerate the drug. They'll also perform tests to see how phenserine affects memory, thinking, and overall brain function, to see if it helps these areas compared to donepezil.
Key takeaways
- This study tests a new drug, phenserine, for early Alzheimer's or mild cognitive impairment.
- It compares phenserine to an existing drug called donepezil (Aricept®).
- Researchers will look at brain changes (biomarkers) and treatment safety.
- It's an early-stage study to find the right dose of phenserine.
- Participation involves regular clinic visits, tests, and taking medication for 8 weeks.
Who may be eligible?
This study is looking for volunteers who are adults, aged 18 or older, and can be any age above that. Both men and women are welcome to take part.
To be considered, you would need to have received a diagnosis of either mild cognitive impairment or early-stage Alzheimer's disease. The research team will do further checks to make sure your specific health situation matches what is needed for the study.
There will also be other criteria that you'd need to meet, such as your general health, other medications you might be taking, and specific scores on memory and thinking tests to ensure the study is safe and suitable for you. The study team will discuss all these details with you if you're interested.
- Are you 18 years old or older?
- Have you been diagnosed with mild cognitive impairment or early Alzheimer's disease?
- Are you available to attend regular clinic visits for 8 weeks?
- Are you able to take study medication (tablets) as instructed?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you will be given either the new drug, phenserine, or an existing drug, donepezil (Aricept®), as film-coated tablets. The study is expected to last for a total of 8 weeks, during which you will take your assigned medication regularly.
Throughout the 8 weeks, you will have several visits to the study clinic. These visits will involve various tests and assessments. You can expect to have blood samples taken and possibly a sample of your spinal fluid (called CSF, for 'cerebrospinal fluid') to check those tiny brain markers we discussed. You'll also have checks of your vital signs (like blood pressure), heart readings (ECGs), and lab tests.
Memory and thinking abilities will be assessed using computer tests and a standard test called the MoCA (Montreal Cognitive Assessment) at the beginning and end of the study. You'll also be closely monitored for any side effects, and the research team will keep track of how well you're taking the medication. After the 8-week treatment, there will likely be follow-up appointments to ensure your well-being.
Potential risks and benefits
Locations (1)
- —Norway
Common questions
What is Alzheimer's disease?
Alzheimer's disease is a brain condition that gradually causes problems with memory, thinking, and behaviour. It's the most common cause of dementia.
What does 'Phase 1B' mean?
Phase 1B means it's an early stage of human testing. Researchers are mainly looking at how safe the drug is, what dosage levels are best, and how it affects the body.
What is donepezil (Aricept®)?
Donepezil, also known as Aricept®, is a common medication already used to treat the symptoms of Alzheimer's disease.
Will I know if I'm getting the new drug or the old one?
In many studies like this, participants are 'blinded,' meaning you won't know if you're getting phenserine or donepezil. This helps ensure fair results.
What are 'biomarkers'?
Biomarkers are measurable changes in the body, like levels of certain proteins in blood or spinal fluid, that can give doctors clues about diseases like Alzheimer's.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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