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

NCT06814730 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-09-11

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease, Early Onset

Interventions

DRUG

THN391

THN391, IV infusion, 3\*Q4W (every 4 weeks)

DRUG

Placebo

Placebo for comparison with THN391, IV infusion, 3\*Q4W

Sponsors & Collaborators

  • Therini Bio, Inc.

    lead INDUSTRY

Principal Investigators

  • Bradford Navia, MD, PhD · Therini Bio, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-17
Primary Completion
2026-05-31
Completion
2026-09-30

Countries

  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06814730 on ClinicalTrials.gov