Pilot Clinical Trial to Assess the Safety of NMS-01 in Patients With Mild to Moderate Alzheimer's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorNeumous Inc.
About this trial
A single-center, single-arm, prospective, open-label, pilot clinical trial to evaluate the safety and efficacy of the Focused ultrasound stimulator system (NMS-01) for transient Blood-Brain Barrier (BBB) opening in patients with mild to moderate Alzheimer's disease
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 50 to 85 years, inclusive.
Individuals previously diagnosed with probable Alzheimer's Disease (AD) by a specialist according to the National Institute on Aging and Alzheimer's Association (NIA-AA) 2011 criteria.
Individuals with a previously confirmed positive 18F-Florbetaben (FBB) position emission tmography (PET) scan.
Individuals with a Clinical Dementia Rating (CDR) global score between 1 and 2, inclusive.
Disqualifiers
A severity score greater than 2 on any one of the following items on the Caregiver Administered Neuropsychiatry Inventory (CGA-NPI): "Delusions," "Hallucinations," or "Agitation/Aggression."
An uncontrolled psychiatric disorder/condition that could affect cognitive function or its assessment (e.g., schizophrenia, bipolar disorder, major depression). (However, subjects are permitted if they have been on a stable drug regimen without changes in dosage for at least the past 4 weeks).
Subjects with pulmonary disease (e.g., pneumonia, pulmonary edema) confirmed by chest X-ray.
Subjects with a known sensitivity, allergy, or contraindication to MRI contrast agents (Gadovist® injection) or ultrasound contrast agents (SonoVue®).
Trial design
Design model
Single group
Treatments tested in this trial
NMS-01
DeviceBBB opening by ultrasound
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: NMS-01Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of subjects with successful BBB opening (%)
Time frame
Change from baseline at 1day and 7day2
Proportion of successful BBB opening relative to the number of targets within the application site(%)
Time frame
Change from baseline at Day 1 and Day 73
Accuracy of BBB opening location relative to the pre-targeting location(%)
Time frame
Time Frame: Change from baseline at Day 1 and Day 74
BBB recovery or not at 24 hours (±6 hours) or 7 days(%)
Time frame
Time Frame: Change from baseline at Day 1 and Day 7Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov