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A Double-blind, Randomized, Placebo-controlled Phase 1b Study to Assess Safety, Tolerability and Pharmacokinetics of Multiple Doses of THN391 in Early Alzheimer's Disease
Led by Therini Bio, Inc. · Updated on 2025-09-11
15
Participants Needed
4
Research Sites
17 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating THN391 in people aged 65 to 85 years with Early Alzheimer's disease and cerebral Small Vessel Disease (cSVD). This Phase 1b study aims to assess the safety, tolerability, and how the drug behaves in the body in this patient group. Previous studies tested THN391 in healthy individuals, but this is the first trial involving patients with early Alzheimer's. The study will compare THN391 to a placebo to better understand its effects. Participants will be randomly assigned to receive one of several doses of THN391 or a placebo via intravenous infusion. Three doses will be given once a month over two months, followed by a four-month follow-up period. The study includes multiple ascending dose groups, and based on early results, the size of later groups may change or new dose groups may be added. During the study, participants will visit the clinic about 13 times and have 2 telephone calls. Assessments will include blood tests, physical and neurological exams, and cognitive tests to evaluate memory and thinking. Imaging such as four brain MRI scans and two spinal taps will be done. Researchers will monitor safety through adverse events, vital signs, ECGs, and mental health assessments throughout the 6 to 8 months of participation.
CONDITIONS
Brief 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
- Be aged 65 to 85 years at the time of consent
- Have a diagnosis of Early Alzheimer's Disease
- Have cerebral Small Vessel Disease and at least one vascular risk factor: hypertension, Type 2 diabetes mellitus, or hyperlipidemia
You will not qualify if you...
- Diagnosis of moderate or severe dementia
- Any other significant medical condition besides early Alzheimer's Disease that could affect study assessments
- Use of anticoagulants except clopidogrel or low dose aspirin unless taken together
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 2 months
Participants receive three monthly intravenous infusions of THN391 or placebo. Clinical and laboratory safety assessments, pharmacodynamics, immunogenicity, and pharmacokinetic blood collections are performed at various time points during treatment.
3 monthly visits (in-person)
Duration - 4 months
Participants are monitored for safety and tolerability after treatment ends with clinical assessments, laboratory tests, brain MRIs, spinal taps, and other evaluations of Alzheimer's disease severity and mental health.
Periodic visits over 4 months
Trial Site Locations
Total: 4 locations
1
Amsterdam UMC
Amsterdam, New Hampshire, Netherlands
Actively Recruiting
2
CTC-Netherlands
Groningen, Netherlands, 9713 EZ
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3
Scottish Brain Sciences
Edinburgh, United Kingdom, EH12 9DQ
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4
University College London Hospitals
London, United Kingdom, WC1N 3BG
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Research Team
B
Bradford Navia, MD, PhD
T
Tanja Hoffman
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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