RECRUITINGPhase 1INTERVENTIONAL

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

A Double-blind, Randomized, Placebo-controlled, Phase 1b Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of THN391 in Early Alzheimer's Disease Subjects

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Be willing and able to understand the study procedures and the risks involved and provide written willing to sign a consent form before the first study-related activity - 65 to 85 years of age (inclusive at the time of willing to sign a consent form). - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

THN391

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

DRUG

Placebo

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

Locations (4)

Amsterdam UMC

Amsterdam, New Hampshire, Netherlands

CTC-Netherlands

Groningen, Netherlands

Scottish Brain Sciences

Edinburgh, United Kingdom

University College London Hospitals

London, United Kingdom