NCT06595511 · RECRUITING

Effects of Combined 40 Hz Audio-visual Stimulation and Cognitive Games on Alzheimer's Disease

This trial tests a device that combines flashing lights and sounds at 40 Hz with digital cognitive games to see whether it slows cognitive decline in Alzheimer's patients. Researchers will track changes using EEG brain recordings, neurological exams, and cognitive tests over three months. It is a Phase NA trial, meaning this is likely a feasibility or development study — not yet a large-scale test of whether it works.

Eligibility criteria

Inclusion and Exclusion Criteria for Alzheimer Patients:
Inclusion Criteria:
* Diagnosed with AD according to DSM-IV and NINCDS-ADRDA criteria,
* Impaired activities of daily living,
* Having a CDR score of 1-2 and an SMMT score of 15-26,
* Stable use of psychoactive medications, including acetylcholinesterase inhibitors or other medications that enhance cognitive functions,
* Individuals aged 60-86 with at least 5 years of education.
Exclusion Criteria:
* Having frontotemporal dementia, vascular dementia, Lewy body dementia or other types of dementia,
* Parkinsonism, clinical depression, other mental disorders, epilepsy, drug addiction, alcohol addiction, and traumatic brain injury
Inclusion and Exclusion Criteria of Healthy Older Adults:
Inclusion criteria:
* Between the ages of 60-86
* Without any neurological abnormalities or general cognitive impairment (MMSE above 25),
* Not diagnosed with a neurological and/or psychiatric disease,
* Not using neurological and/or psychiatric medication
Exclusion criteria
* Having clinical signs of cognitive impairment, such as mild cognitive impairment, Alzheimer disease, Parkinson disease, Lewy body dementia, frontotemporal dementia, etc.
* Epilepsy, alcohol and/or drug addiction, use of medications that affect cognitive functions, and traumatic brain injury

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2024-09-19

View full record on ClinicalTrials.gov

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