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

Launched by THERINI BIO, INC. · Feb 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called THN391 to see how safe it is and how it works in people with Early Alzheimer's Disease. This is the first time THN391 is being tested in patients who have Alzheimer's, after being tested in healthy individuals. The study will last about six months, during which participants will receive either THN391 or a placebo (a substance that looks like the drug but has no active ingredients) in a clinic. Participants will have around 13 visits to the clinic and two phone calls to help researchers gather information about the drug's effects.

To be eligible for this trial, participants should be between 65 and 85 years old, have a diagnosis of Early Alzheimer's Disease, and also have a condition called cerebral Small Vessel Disease along with certain risk factors like high blood pressure or diabetes. It's important for participants to understand the study and agree to take part by signing a document. Throughout the trial, participants will undergo various tests, including blood tests, brain scans, and memory assessments to monitor their health and the drug's effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
• • 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:
• • Diagnosis of moderate or severe dementia
• • 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