A Study to Assess THN391 in Subjects With Alzheimer's Disease
ConditionAlzheimer Disease, Early Onset
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age65-85
SponsorTherini Bio, Inc.
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- THN391
- Placebo
Treatment groups
15 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov