NCT07866768Toboroz
CMN LIFU for Enhanced Glymphatic Clearance in Amyloid-Positive MCI
Safety and Feasibility Study of ATTN201 Centromedian Nucleus of the Thalamus Focused Ultrasound Stimulation for Enhanced Glymphatic Clearance in Amyloid Positive Patients With Mild Cognitive Impairment
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 14.
Rövid összefoglaló (regiszter, angolul)
The goal of this clinical trial is to learn if a wearable ultrasound device, called ATTN201, is safe and easy to use. The study is for adults ages 65 and older who have mild cognitive impairment (MCI) and a buildup of a protein called amyloid in the brain. Amyloid buildup is an early sign of Alzheimer's disease. The ATTN201 device sends low-intensity sound waves to a deep area of the brain that helps control sleep. The aim is to boost deep-sleep brain waves. These brain waves may help the brain clear away waste, including amyloid. The main questions it aims to answer are: 1. What, if any, issues do participants have when using the ATTN201 device? 2. Can participants complete the full study schedule? Researchers will compare focused ultrasound to unfocused ultrasound. Unfocused ultrasound is a look-alike treatment. It feels and sounds the same but is not aimed at the brain target. The comparison will show if the focused treatment changes sleep brain waves, blood markers of Alzheimer's disease, or memory and thinking. Participants will: * Visit the study site for memory and thinking tests, blood draws, a health check, and MRI scans of the brain * Record their sleep at home for at least 5 days with a sleep diary, a watch-like sensor, and a headband that measures brain waves * Be assigned by chance to focused or unfocused ultrasound * Take part in 10 nap sessions over 2 weeks while wearing the device, at the study site or at home * Return for a final visit to repeat the first tests, and may return for an optional visit 3 months later
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 28 (tervezett)
- Első benyújtás
- 2026. aug. 20.
- Kezdés
- 2026. okt.
- Elsődleges befejezés
- 2028. jan.
- Fő szponzor
- University of California, San Francisco
- Betegségek
- Alzheimer-kór
- NCT-szám
- NCT07866768
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 28
- 2026. okt. és az elsődleges befejezés (2028. jan.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Early-onset Alzheimer's disease, as defined by a diagnosis occurring prior to age 65.
- Is on medication which, in the opinion of the investigator, will confound study results.
Más betegség
- Has other medical or psychiatric symptoms or conditions that, in the opinion of the investigator, will interfere with study activities or confound interpretation of study results.
- Has a history of deep brain stimulation or ablative surgery
- Has a history of substance abuse including alcohol use disorder in the past 6 months
- Has a history of traumatic brain injury
- Has an uncontrolled medical condition which may impact study results.
Egyéb
- Clinically significant depression, as defined by a score of >10 on the Geriatric Depression Scale
- Moderate to severe untreated obstructive sleep apnea, as defined by an Apnea-Hypopnea Index (AHI) ≥ 15.
- Has any contraindications for completing a brain MRI scan.
- The subject's head must fit within the head coil.
- Is or has an immediate family member of staff directly involved with this trial.
Kiket keres a vizsgálat
- 65+ years old, male or female
- Amyloid positivity as assessed by either PET, CSF, or plasma.
- Qualify for an MCI Diagnosis.
- Study partner available for informant measures.
- Willing and able to undergo a brain MRI.
- If currently on AD or sleep medications, must be at the same stable dose(s) for at least 3 weeks prior to screening and throughout the course of the study, and must continue to be under the care of their treating neurologist through the duration of the study.
- Be able and willing to wear an Attune device during treatments
- Able to sign informed consent in accordance with local regulations.
- Be able to speak, read, and understand the language of the trial staff and the informed consent form.
- Possess the ability to respond verbally to questions, follow instructions, and complete study assessments.
- Be able to adhere to the stimulation protocol and visit schedules.
- Be medically stable at baseline/randomization as assessed by medical history and non-significant clinical results of safety labs and vital signs examination.
Életkor a regiszterben: 65 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of California San Francisco | San Francisco | Egyesült Államok | Toboroz |
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