Acoustic Stimulation During Sleep for Alzheimer’s Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares active acoustic stimulation during NREM sleep to a sham condition in individuals with mild cognitive impairment linked to Alzheimer's disease. Participants will receive brief, familiar sounds at regular intervals during stable NREM sleep, with cognitive tests and sleep EEGs conducted before and after the treatment period. The goal is to assess potential cognitive benefits, safety, and feasibility of this approach. The study randomizes 40 participants (20 per group) and uses caregiver involvement to support participation. No phase information is provided for this trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

\- (1) Meets the diagnostic criteria for mild cognitive impairment (according to Petersen criteria): ① insidious onset; ② memory impairment is the primary complaint; ③ objective evidence of memory decline (defined quantitatively as a decline of more than 1.5 standard deviations below age- and education-matched controls); ④ may be accompanied by other cognitive impairments, but memory decline is more prominent; ⑤ general cognitive function is normal; ⑥ preservation of activities of daily living, with an Activities of Daily Living (ADL) scale score \<23; ⑦ does not meet the diagnostic criteria for dementia; ⑧ imaging findings support the diagnosis.

(2) Amyloid PET positivity or reduced cerebrospinal fluid amyloid levels. (3) The patient should have a stable and reliable caregiver, or at least be able to maintain frequent contact with a caregiver. The caregiver must be able to accompany and assist the patient throughout the entire study, must accompany the subject to study visits, and must have sufficient interaction and communication with the subject to provide valuable information for the scoring of various scales.

Exclusion Criteria:

* (1) Presence of memory and cognitive decline caused by other non-AD conditions, such as other types of dementia, including but not limited to mixed dementia (AD-VaD), vascular dementia (VD), Parkinson's disease dementia (PDD), dementia with Lewy bodies (DLB), Huntington's disease-related dementia, and frontotemporal dementia (FTD); endocrine disorders (e.g., thyroid disease, parathyroid disease); folate or vitamin B12 deficiency; or dementia caused by any other reason.

  (2) At screening, MRI shows significant focal lesions: more than 2 infarcts with a diameter greater than 2 cm, or infarcts in key regions such as the thalamus, hippocampus, entorhinal cortex, perirhinal cortex, angular gyrus, and other cortical and subcortical gray matter nuclei.

  (3) Presence of moderate to severe white matter degeneration (Fazekas score 3-6).

  (4) Presence of metallic foreign bodies or other implanted electronic devices, or claustrophobia, etc., which preclude TMS treatment or MRI scanning.

  (5) Severe visual, auditory, motor, or consciousness impairment that prevents cooperation with examinations and treatment.

  (6) History of seizures (presence of at least 2 unprovoked seizures occurring more than 24 hours apart, or diagnosis of an epilepsy syndrome, or a seizure within the past 12 months).

  (7) Acute cardiovascular or cerebrovascular events (e.g., unstable angina, severe arrhythmia, myocardial infarction, transient ischemic attack, or ischemic stroke) within 3 months before screening.

  (8) Severe systemic diseases involving the heart, lungs, liver, kidneys, etc., identified by laboratory tests or examinations, and not controlled by conventional medication.

  (9) Patients with concurrent malignant tumors; or patients with a life expectancy of less than 1 year due to causes other than AD.

  (10) History of alcohol or drug abuse. (11) Received other TMS treatment within 3 months. (12) Participated in or is currently participating in another clinical trial within 3 months.

Where it's running

• Xuanwu hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Tao Wei, MD
• Email: twei2019@126.com
• Phone: 15650228107

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.