NCT06814730 A Study to Assess THN391 in Subjects With Alzheimer's Disease
| NCT ID | NCT06814730 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Therini Bio, Inc. |
| Condition | Alzheimer Disease, Early Onset |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-07-17 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2025-07-17 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 * 65 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
Contact & Investigator
Bradford Navia, MD, PhD
STUDY DIRECTOR
Therini Bio, Inc.
Frequently Asked Questions
Who can join the NCT06814730 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 85 Years, studying Alzheimer Disease, Early Onset. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06814730 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06814730 currently recruiting?
Yes, NCT06814730 is actively recruiting participants. Contact the research team at bnavia@therinibio.com for enrollment information.
Where is the NCT06814730 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Groningen, Netherlands, Edinburgh, United Kingdom, London, United Kingdom.
Who is sponsoring the NCT06814730 clinical trial?
NCT06814730 is sponsored by Therini Bio, Inc.. The principal investigator is Bradford Navia, MD, PhD at Therini Bio, Inc.. The trial plans to enroll 15 participants.
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