Actively Recruiting
Neuclare Device for Temporary Improvement of Executive Function in Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease
Led by Deepsonbio · Updated on 2025-12-10
138
Participants Needed
3
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, randomized, double-blind, parallel-group, prospective confirmatory clinical trial designed to evaluate whether the Neuclare medical device can temporarily improve executive function (planning and problem-solving abilities) in adults with mild cognitive impairment or very early Alzheimer's disease. Participants will continue their current medication and be randomly assigned to receive either the Neuclare device (treatment group) or a sham device (control group). The device will be applied to the brain three times per week for four weeks. Both participants and study staff are blinded to the group assignment. Safety and adverse events will be closely monitored throughout the study. During the trial, assessments will include attention, cognitive function, daily living activities, brain imaging (Amyloid PET-CT), blood biomarkers, and quality of life (EQ-5D-5L). The goal of this study is to determine whether the Neuclare device, in combination with standard medication, can safely provide temporary improvements in executive function.
CONDITIONS
Official Title
Neuclare Device for Temporary Improvement of Executive Function in Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 55 to 90 years.
- Diagnosed with probable Alzheimer's disease according to NINCDS-ADRDA criteria and DSM-IV criteria for dementia,
- or mild cognitive impairment/very mild Alzheimer's disease with CDR 0.5-1 and MMSE-II ≥18.
- On stable cognitive therapy medications for at least 1 month.
- Voluntary participation with signed informed consent.
You will not qualify if you...
- Patients with structural brain lesions detected on brain MRI (e.g., cerebral edema, intracerebral hemorrhage, cerebral infarction, cerebrovascular malformation, brain tumor, etc.).
- Patients with uncontrolled metabolic disorders such as thyroid dysfunction, hypoglycemia, or hepatic/renal impairment, or those on long-term medications that may cause cognitive impairment (e.g., anticholinergic drugs).
- Patients with a history of epileptic seizures, depression, or psychiatric disorders; patients experiencing visual hallucinations or fluctuating cognitive decline.
- Patients with psychiatric disorders outside of the inclusion criteria.
- Patients with a history of severe diseases such as cancer or tuberculosis.
- Patients with a history of or currently taking psychoactive drugs or medications affecting the central or peripheral nervous system.
- Patients with contact dermatitis or other skin hypersensitivity conditions.
- Patients with fever ≥ 40°C as measured by tympanic temperature.
- Patients who have experienced bleeding within the past 3 months due to procedures or surgeries that may affect vital signs.
- Patients unable to undergo MRI.
- Pregnant patients.
- Patients with clinical brain calcification observed on computed tomography (CT) scans.
- Patients with known allergies to contrast agents such as Definity or Gadovist.
- Any other condition deemed by the investigator to make participation in the clinical trial inappropriate.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, South Korea, 18450
Not Yet Recruiting
2
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
3
Ewha Womans University Mokdong Hospital
Seoul, South Korea, 07985
Actively Recruiting
Research Team
S
Sung Kyung Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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