Clinical trial · Interventional
The Pilot Study of Medical Device-Neuclare for Patients With Mild Cognitive Disorder and Early Dementia
A Prospective Pilot Study to Evaluate Efficacy and Safety of Medical Device-Neuclare in Patient With Mild Cognitive Disorder and Early Dementia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial aims to explore the effectiveness and safety of cognitive function improvement of Neuclare, a science medical device, for patients with mild cognitive impairment and early Alzheimer's disease. Through methods such as Trail Making Test Black \& White, Attention Questionnaire Scale(AQS), Neuropsychiatric Inventory (NPI), etc, cognitive function improvement before and after using Neuclare will be evaluated.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Disorder Mild | — | UNRESOLVED | — |
| Dementia, Mild | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neuclare | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- The patient with mild cognitive disorder and early dementia who will be treated with the medical device-Neuclare
- interventionNames
- Device: Neuclare
Primary outcomes (1)
- measure
- Change of Trail Making Test Black & White Score : From Baseline to Week 5
- timeFrame
- Week 5
- description
- Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Trail Making Test Black \& White Score
Secondary outcomes (7)
- measure
- Change of Attention Questionnaire Scale : From Baseline to Week 5
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged 55 to 90 * Patients who meet "Probable Alzheimer's disease" and "Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)" criteria for dementia * Patients with CDR (clinical dementia rating) from 0.5 to 1 and MMSE-II over 18 * Upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions Exclusion Criteria: * Patient with pathological lesions in the brain identified by MRI * Patients with metabolic disorders such as thyroid dysfunction, hyperglycemia, hypoglycemia, liver or kidney dysfunction, and long-term use of drugs that will cause cognitive decline (e.g., anticholinergic drugs) * History of epileptic seizures or depression or psychiatric abnormalities or with visual acuity and fluctuations in cognitive decline * History of psychiatric disorder other than the inclusion criteria. * A person with a severe history of cancer/tuberculosis * A person who has or is taking psychiatric or peripheral/central nervous system drugs * A person who has contact dermatitis or sensitive skin abnormalities * Patients with a high fever of 40 degrees or higher based on eardrum body temperature * A person whose bleeding is identified within the last 3 months due to a common procedure/surgery that may affect vital signs * A person who is unable to perform MRI tests * Pregnant women * Patient with calcification in the brain identified by CT * Patient with allergic to contrast agents such as Definity or Gadovist * Other cases where the investigator judged that it is difficult to participate in the study;
References
Publications (0)
Data not yet available