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 depends on the number of dose administrations: for the 3 doses administration, the duration is approx. 8 months, in which the participants will visit the clinic approximately 13 times and have 2 telephone calls with the site. For the 6 doses administration group (starting in Jan 2026), the duration is approx. 11 months, with 19 clinic visits and 5 telephone calls with the site. Patients who fulfill all criteria to participate in the study, will receive 3 or 6 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, 5-7x an MRI-scan of the head, 3x a spinal tap and some testing of the memory and thinking skills.
Age range
60 Years – 85 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
To assess the safety and tolerability of multiple doses of THN391 in Early AD subjects via AEs
Timeframe: From enrollment to the end of the follow-up period (6 months post dosing)
To assess the safety and tolerability of multiple doses of THN391 in Early AD subjects via SAEs
Timeframe: From enrollment to the end of the follow-up period (6 months post dosing)
To assess the pharmacokinetics (PK) of multiple doses of THN391 in Early AD subjects
Timeframe: From the first dosing to the end of the follow-up period (6 months post dosing)
To assess the maximum plasma concentration (Cmax) for THN391 in Early AD subjects
Timeframe: From the first dosing to the end of the follow-up period (6 months post dosing)
To assess area under the curve concentration (AUC) for THN391 in Early AD subjects
Timeframe: From the first dosing to the end of the follow-up period (6 months post dosing)
To measure the half-life (t1/2) of THN391 in Early AD subjects
Timeframe: From the first dosing to the end of the follow-up period (6 months post dosing)