RecruitingPhase 1NCT06814730

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

A Double-blind, Randomized, Placebo-controlled, Phase 1b Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of THN391 in Early Alzheimer's Disease Subjects

Sponsor

Therini Bio, Inc.

Enrollment

15 participants

Start Date

Jul 17, 2025

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease, Early Onset

Summary

This is a Phase 1b study to evaluate different doses of the drug and see whether a drug is safe and how it behaves in the body. THN391 has already been assessed in healthy people without Alzheimer's disease. This is the first study of THN391 in patients with Early Alzheimer's disease. Later studies will evaluate THN391 to see if it is effective for the treatment of Alzheimer's disease. In this study, THN391 will be compared with a placebo (a look-alike substance that contains no drug). The study duration is approximately 6 months in which the participants will visit the clinic approximately 13 times and have 2 telephone calls with the site. Patients who fulfill all criteria to participate in the study, will receive 3 times a monthly dose of THN391 or placebo in the clinic. Assessments that will be done at several timepoints during the study will be blood collection, physical examinations and neurological examinations, 4x an MRI-scan of the head, 2x a spinal tap and some testing of the memory and thinking skills.

Eligibility

Min Age: 65 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called THN391 in people with early Alzheimer's disease who also have small vessel disease in the brain — tiny blood vessel damage that is common in aging and linked to vascular risk factors. Researchers believe that improving blood flow to the brain may help slow Alzheimer's progression, and this drug is designed to target that process. **You may be eligible if...** - You are between 65 and 85 years old - You have been diagnosed with early (mild) Alzheimer's disease - You also have cerebral small vessel disease - You have at least one vascular risk factor: high blood pressure, type 2 diabetes, or high cholesterol **You may NOT be eligible if...** - You have moderate or severe dementia - You have another significant neurological or psychiatric condition besides early Alzheimer's - You are on blood thinners (anticoagulants) other than clopidogrel or low-dose aspirin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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