A Study to Assess THN391 in Subjects With Alzheimer's Disease
NCT ID: NCT06814730
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
15 participants
INTERVENTIONAL
2025-07-17
2026-09-30
Brief Summary
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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.
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Detailed Description
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The study duration is 6-8 months: first screening to assess eligibility, then 2 months' treatment period (3 monthly doses), followed by a 4 month follow-up period.
The trial will investigate THN391 in at least 3 dose cohorts, Depending on preliminary, blinded results of the first two cohorts, the sample sizes of the following dose cohort may be increased and/or additional dose cohorts may be added.
Eligible participants will be randomized to receive either THN391 or placebo.
Three dose administrations will be provided monthly. Participants will undergo clinical and laboratory-based safety-related assessments, as well as Pharmacodynamics (PD), immunogenicity, and blood Pharmacokinetic (PK) collections at different time points.
Assessments will include 4 brain MRIs (Magnetic Resonance Imaging), 2 spinal taps, electrocardiograms (ECGs), vital signs, physical and neurological examinations, adverse event recordings, monitoring of mental health, and tests to determine the severity of Alzheimer's disease.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1
THN391 (low dosage) or Placebo, IV-infusion
THN391
THN391, IV infusion, 3\*Q4W (every 4 weeks)
Placebo
Placebo for comparison with THN391, IV infusion, 3\*Q4W
Cohort 2
THN391 (medium dosage) or Placebo, IV-infusion
THN391
THN391, IV infusion, 3\*Q4W (every 4 weeks)
Placebo
Placebo for comparison with THN391, IV infusion, 3\*Q4W
Cohort 3
THN391 (high dosage) or Placebo, IV infusion
THN391
THN391, IV infusion, 3\*Q4W (every 4 weeks)
Placebo
Placebo for comparison with THN391, IV infusion, 3\*Q4W
Interventions
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THN391
THN391, IV infusion, 3\*Q4W (every 4 weeks)
Placebo
Placebo for comparison with THN391, IV infusion, 3\*Q4W
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
85 Years
ALL
No
Sponsors
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Therini Bio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bradford Navia, MD, PhD
Role: STUDY_DIRECTOR
Therini Bio, Inc.
Locations
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Amsterdam UMC
Amsterdam, New Hampshire, Netherlands
CTC-Netherlands
Groningen, , Netherlands
Scottish Brain Sciences
Edinburgh, , United Kingdom
University College London Hospitals
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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C. Mummery, Prof., MD, PhD
Role: primary
Role: backup
Other Identifiers
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2024-519899-72-00
Identifier Type: CTIS
Identifier Source: secondary_id
THN391-NEU-102
Identifier Type: -
Identifier Source: org_study_id
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