RecruitingPHASE1INTERVENTIONAL

A Study to Assess THN391 in Subjects With Alzheimer's Disease

This research study is looking at a new drug called THN391 for people aged 65 to 85 who have early-stage Alzheimer's disease and a condition called small vessel disease. It's a Phase 1b study, which means the main goal is to check the drug's safety and how it works in the body at different doses. Participants will receive either THN391 or a placebo (a dummy drug with no active ingredients). The study lasts about 6 months, involving monthly clinic visits for doses, along with blood tests, physical and brain scans (MRI), and memory assessments. THN391 has been tested in healthy people, and this is its first study in people with Alzheimer's. Future studies would look at whether the drug is effective in treating the disease.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Therini Bio, Inc.

Enrolment target

Start

17 Jul 2025

Estimated completion

30 Sep 2026

Alzheimer Disease, Early Onset

What is this study about?

This research study is looking into a new medication, THN391, for people diagnosed with early-stage Alzheimer's disease who also have a condition called cerebral small vessel disease (cSVD). This is a Phase 1b study, which means it's one of the first times this drug is being tested in people with the condition. The main aims are to understand if THN391 is safe, how it behaves in the body, and to find the right doses. This is a crucial step before larger studies can investigate whether the drug can actually help treat Alzheimer's disease.

Participants in this study will receive either THN391 or a placebo. A placebo looks exactly like the real drug but contains no active medicine. This helps researchers understand the true effects of THN391 by comparing it to what happens with the placebo. Neither you nor the study team will know whether you are receiving the active drug or the placebo, which is a standard way to ensure results are as fair and unbiased as possible.

THN391 has already been tested in healthy volunteers, so this study marks an important step by testing it for the first time in people living with early Alzheimer's disease. The information gathered from this and similar early-stage studies is vital for deciding whether to proceed with further research to see if THN391 could eventually become a treatment option.

Key takeaways

This is an early-stage study (Phase 1b) for a potential new Alzheimer's drug, THN391.
It aims to check the safety of THN391 and how it works in the body.
Participants will receive either THN391 or a dummy drug (placebo).
The study lasts about 6-8 months and involves clinic visits, blood tests, MRI scans, and spinal taps.
It's for people aged 65-85 with early Alzheimer's and small vessel disease.
Your participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is specifically designed for people between 65 and 85 years old. To be considered, you must have an official diagnosis of early-stage Alzheimer's disease. Additionally, you need to have cerebral small vessel disease (cSVD) and at least one of these conditions: high blood pressure, type 2 diabetes, or high cholesterol.

There are also some reasons why you might not be able to join. These include having moderate or severe dementia, or any other significant health problem (apart from early Alzheimer's) that might make it hard to accurately assess the study's results. Certain blood-thinning medications, except for low-dose aspirin or clopidogrel (unless taken together), would also prevent participation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 65 and 85 years old?
Do you have a diagnosis of early-stage Alzheimer's disease?
Do you also have cerebral small vessel disease (cSVD)?
Do you have high blood pressure, type 2 diabetes, or high cholesterol?
Do you NOT have moderate or severe dementia?
Are you NOT taking certain blood-thinning medications (except low-dose aspirin or clopidogrel, unless taken together)?

Answer every question to see your result.

What does participation involve?

If you join this study, your participation will last about 6 to 8 months. Initially, you'll have a screening appointment to check if you're suitable. The treatment period involves receiving the study drug (THN391 or placebo) once a month for three months, usually at a clinic. Following this, there's a 4-month follow-up period.

Throughout the study, you'll have approximately 13 visits to the clinic and 2 phone calls with the study team. These visits will involve various assessments, including blood tests, general health checks, nerve examinations, and tests to evaluate your memory and thinking skills. You will also have 4 MRI scans of your head and 2 spinal taps (where a small sample of fluid is taken from your spine) to gather important information about the drug's effects.

Potential risks and benefits

Participating in a clinical trial means you might be among the first to receive an investigational drug, which could potentially offer a benefit if the drug proves effective. However, as THN391 is still in early development, it's possible it may not help your condition, and there's a risk of side effects, some of which may be unknown. Standard medical procedures like blood tests, MRI scans, and spinal taps also carry their own small risks. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Amsterdam UMC
Verified postcode
Amsterdam, Netherlands· Recruiting
CTC-Netherlands
Verified postcode
Groningen, Netherlands· Recruiting
Scottish Brain Sciences
Verified postcode
Edinburgh, United Kingdom· Recruiting
University College London Hospitals
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a Phase 1b study?

It's an early-stage study that primarily focuses on checking the safety of a new drug and how it works in the body, rather than whether it cures a disease. It also helps find the right doses.

What is a 'placebo'?

A placebo is a look-alike substance or treatment that contains no active drug. It helps researchers compare the effects of the actual medicine with what happens when no medicine is given.

Will I know if I'm getting THN391 or the placebo?

No, neither you nor the study team will know whether you are receiving the active drug or the placebo during the study. This is called 'double-blind' and helps ensure the results are fair.

What is cerebral small vessel disease (cSVD)?

cSVD is a condition that affects the small blood vessels in the brain, which can impact brain function. It's often linked to conditions like high blood pressure or diabetes.

How long will I be involved in the study?

If you are eligible and choose to participate, your involvement will last for approximately 6 to 8 months.

How to find out more

Bradford Navia, MD, PhD

bnavia@therinibio.com +16173205611 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.