An interventional study of 40 Hz Synchronous Audio-Visual Stimulation and Sham Audio-Visual Stimulation in Alzheimer's Disease Related Dementia, sponsored by The First Affiliated Hospital of Xiamen University. Not yet recruiting at 1 site in China. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by The First Affiliated Hospital of Xiamen University · Not applicable, Interventional, and Treatment
This is a single-center, parallel-group, double-blind randomized controlled trial conducted at the First Affiliated Hospital of Xiamen University, enrolling 50 participants with Alzheimer's disease (AD)-derived mild cognitive impairment (MCI) or mild AD aged 50-80 years with ≥4 years of education. Subjects must meet diagnostic criteria per Chinese AD guidelines, show medial temporal lobe atrophy on baseline brain MRI, have a reliable caregiver, and be capable of completing all assessments. Exclusion criteria include severe visual/auditory impairment, non-AD dementia, recent neuromodulation therapy, uncontrolled severe systemic diseases, prominent psychiatric disorders, significant cerebral focal lesions on MRI, and other conditions precluding safe participation.
Eligible participants will be randomly assigned to either the 40 Hz audio-visual stimulation group or the placebo group. The intervention lasts 1 hour once daily for 12 weeks, with a total subject follow-up period of 36 weeks (12-week treatment + 24-week observational follow-up). The primary efficacy outcome is the change from baseline in the 11-item Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) at the end of treatment. Secondary outcomes include changes in Mini-Mental State Examination (MMSE) and ADCS-Activities of Daily Living (ADCS-ADL) scores across all follow-up visits. Exploratory biomarkers cover plasma Aβ42, Aβ40, Tau-217, gamma wave power on electroencephalography (EEG), and repeat Aβ-PET imaging (if previously performed). Cognitive, functional, emotional, EEG, and blood biomarker assessments will be conducted at scheduled time points. Safety monitoring focuses on intervention-related adverse events such as headache and dizziness, with detailed recording of onset, duration and accompanying symptoms.
Statistical analyses will use two-sided tests at α=0.05. Linear mixed models and repeated-measures ANOVA with ANCOVA adjustment for covariates will analyze the primary endpoint; appropriate parametric or nonparametric tests will be applied for secondary and exploratory outcomes. Baseline group balance will be compared via t-tests, Mann-Whitney U tests or chi-square tests. All data processing and statistical modeling will be performed using Python 3.11 and related analytical packages. The trial runs from July 2026 to December 2027.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →The First Affiliated Hospital of Xiamen University is the lead sponsor of 119 studies on the registry; 80 are open to participants now.
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Inclusion Criteria Subjects diagnosed with Alzheimer's disease-derived mild cognitive impairment (AD-MCI) or mild Alzheimer's dementia, diagnosed in accordance with Chinese Guidelines for the Diagnosis and Treatment of Alzheimer's Dementia (2020 Edition) and Chinese Expert Consensus on the Diagnosis and Treatment of AD-derived Mild Cognitive Impairment (2021).
Clinical Dementia Rating sum of boxes (CDR-SB) score ranges from 0.5 to 1. Age between 50 and 80 years old, with education ≥ 4 years, any biological sex. Able to cooperate with 12-week intervention and all scheduled assessments including cognitive scales, EEG, blood tests and brain imaging.
Subject or legal guardian provides written and agrees to comply with study procedures.
Baseline brain MRI with coronal hippocampal sequence shows medial temporal lobe atrophy (MTA) grade ≥2, highly suggestive of AD pathology.
Has a stable, reliable caregiver throughout the study period. Exclusion Criteria Severe visual impairment (uncorrected visual acuity \<0.1, unable to detect flickering light) or severe hearing loss (pure tone audiometry ≥60 dB, cannot perceive 40 Hz auditory stimulation).
Cognitive decline caused by non-AD etiologies: vascular dementia, mixed dementia, dementia with Lewy bodies, Parkinson's disease dementia, frontotemporal dementia, Huntington's disease, cognitive impairment secondary to thyroid disorders, vitamin B12/folate deficiency, or other organic brain diseases.
Received other neuromodulation therapies (TMS, tDCS, etc.) within 3 months prior to screening or participated in other interventional cognitive trials recently.
Uncontrolled severe systemic diseases: advanced heart failure, arrhythmia, hypertension, severe hepatic/renal dysfunction, active malignant tumors.
History of schizophrenia, mania or other severe psychiatric disorders; GDS ≥15 or HAMA ≥14 at screening; receiving antidepressant, anxiolytic or antipsychotic medication at screening.
Hachinski Ischemic Score (HIS) >4. Baseline MRI shows significant focal cerebral lesions: ≥2 infarcts >2 cm; infarcts in thalamus, hippocampus, entorhinal cortex or angular gyrus; Fazekas white matter hyperintensity grade ≥3.
Active , syphilis, /C or other severe chronic infectious diseases.
Severe communication disorders or altered consciousness preventing completion of assessments or intervention.
Refusal of informed consent by legal guardian. Any other clinical condition judged by investigators to make the subject unsuitable for participation.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: 40 Hz Synchronous Audio-Visual Stimulation
Device: Sham Audio-Visual Stimulation
Non-invasive audio-visual neuromodulation device generating synchronized 40 Hz light flicker and sound stimulation. Subjects receive 1 session daily, 1 hour per session, for a total of 12 consecutive weeks. After intervention, 24 weeks of observational follow-up without stimulation is performed.
Identical external device appearance with non-therapeutic low-frequency light and sound signals without 40 Hz gamma oscillation. Administration frequency, duration and operation process are completely consistent with the experimental group, once daily for 1 hour over 12 weeks, followed by 24 weeks of off-treatment follow-up.
Change from baseline in the 11-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) total score at Week 12 (end of intervention)
Time frame: Baseline and Week 12 (12 weeks after randomization)
Change from baseline in ADCS-Activities of Daily Living (ADCS-ADL) total score
Time frame: Baseline, Week 12, Week 36
Changes in plasma Aβ42, Aβ40 and Tau-217 levels from baseline
Time frame: Baseline, Week 12
Changes on Aβ-PET imaging (if baseline Aβ-PET was performed)
Time frame: Baseline, Week 12 (only for subjects with baseline Aβ-PET scan)
Changes in electroencephalography (EEG) gamma wave power from baseline
Time frame: Baseline, Week 12, Week 36
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The First Affiliated Hospital of Xiamen University →