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New Alzheimer's drug THN391 enters first patient trial

NCT ID NCT06814730

Disease control Sponsor: Therini Bio, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study tests an experimental drug called THN391 in 15 people with early Alzheimer's disease who also have small vessel disease in the brain. Participants receive three monthly IV infusions of either THN391 or a placebo. The main goal is to check safety and how the drug behaves in the body, not yet whether it helps memory or thinking.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
THN391 (an experimental drug given by IV infusion)
What this could lead to
If this drug is safe and well-tolerated, it could pave the way for larger studies to see if THN391 can slow or treat Alzheimer's disease.
What could go wrong
This is a very early, small study (15 people) focused only on safety and drug levels—not on whether it works. Many drugs that look safe in Phase 1 fail later. There may be side effects or no benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

19 people

The number who actually took part.

Started

Jul 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity * 60 to 85 years of age (inclusive at the time of informed consent). * Diagnosis of Early Alzheimer's Disease (AD) * Diagnosis of cerebral Small Vessel Disease (cSVD), and having at least one of the following vascular risk factors: hypertension, Type 2 diabetes mellitus, or hyperlipidemia Exclusion criteria: * Diagnosis of moderate or severe dementia * Any other medical condition except for early AD (e.g. any clinically significant neurological, psychiatric or large vessel disease) that could affect interpretation of study assessments * Use of anticoagulant, except for either clopidogrel or low dose aspirin, unless taken simultaneously

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Conditions

The condition(s) this trial relates to.

Alzheimer disease early-onset autosomal dominant Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease, early onset

Contacts and locations

Locations

  • Amsterdam UMC

    Amsterdam, New Hampshire, Netherlands

  • CTC-Netherlands

    Groningen, Provincie Groningen, 9713 EZ, Netherlands

  • Scottish Brain Sciences

    Edinburgh, EH12 9DQ, United Kingdom

  • University College London Hospitals

    London, WC1N 3BG, United Kingdom

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