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New treatment option for Mild Cognitive Impairment
Official title Neuclare Device for Temporary Improvement of Executive Function in Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease
ClinicalTrials.gov ID: NCT07239310
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 90
You may be able to join if
- 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 likely can't join if
- Patients with structural brain lesions detected on brain MRI (e.g., cerebral edema, intracerebral hemorrhage, cerebral infarction, cerebrovascular...
- Patients with uncontrolled metabolic disorders such as thyroid dysfunction, hypoglycemia, or hepatic/renal impairment, or those on long-term...
- Patients with a history of epileptic seizures, depression, or psychiatric disorders; patients experiencing visual hallucinations or fluctuating...
- 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.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hwaseong-si, Gyeonggi-do, South Korea
- Seongnam-si, Gyeonggi-do, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hwaseong-si, Gyeonggi-do, South Korea; Seongnam-si, Gyeonggi-do, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.