Actively Recruiting
A Study to Assess THN391 in Subjects With Alzheimer's Disease
Led by Therini Bio, Inc. · Updated on 2025-09-11
15
Participants Needed
4
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess THN391 in Subjects With Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be willing and able to understand the study procedures and risks and provide written informed consent before any study activity
- Be aged 65 to 85 years at the time of consent
- Have a diagnosis of Early Alzheimer's Disease
- Have a diagnosis of cerebral Small Vessel Disease (cSVD) and at least one vascular risk factor: hypertension, Type 2 diabetes mellitus, or hyperlipidemia
You will not qualify if you...
- Have moderate or severe dementia
- Have any other significant medical condition besides early Alzheimer's disease that could affect study assessments, including neurological, psychiatric, or large vessel diseases
- Use anticoagulant medications other than clopidogrel or low dose aspirin unless taken simultaneously
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Amsterdam UMC
Amsterdam, New Hampshire, Netherlands
Actively Recruiting
2
CTC-Netherlands
Groningen, Netherlands, 9713 EZ
Actively Recruiting
3
Scottish Brain Sciences
Edinburgh, United Kingdom, EH12 9DQ
Actively Recruiting
4
University College London Hospitals
London, United Kingdom, WC1N 3BG
Actively Recruiting
Research Team
B
Bradford Navia, MD, PhD
CONTACT
T
Tanja Hoffman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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