See if three months of visual flicker at 16.67 Hz helps cognition and mood in older adults with or without subjective cognitive concerns

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

Researchers will compare a high-frequency visual flicker intervention (16.67 Hz) to a low-frequency control (1 Hz) over 12 weeks in adults aged 65–89 living at home. The goal is to see if the flicker helps cognition, mobility, and mood and whether it slows brain aging markers and changes in biomarkers related to Alzheimer's disease. The study will monitor brain structure and functional networks, along with blood biomarkers, to understand any biological effects. Participants may be drawn from those with and without subjective cognitive decline and will be assessed at baseline and after the intervention. The design is interventional but does not specify a traditional randomization scheme in the provided information.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Community dwelling men and women 65-89 years old
* Ability to walk unassisted for 10 min
* English speaking Additional Inclusion Criteria for SCD
* No evidence of dementia or MCI based on cognitive screening (i.e., Montreal Cognitive Assessment (MoCA) score within normal limits for age, education, and sex using the NACC Uniform Data Set (UDS) norms
* Global Clinic Dementia Rating (CDR) score must be 0 or 0.531
* Subjective report of cognitive complaints with scores \>20 on the Cognitive Change Index (CCI-20), a validated scale of subjective cognitive decline6; this scale consists of 20 items that are rated on a 5-point Likert scale, where 1= "Normal: No change compared to 5 years ago", 3= "Mild Problem: Some change compared to 5 years ago) and 5="Severe Problem: Much worse compared to 5 years ago"
* Family history of dementia/probable AD in first degree relative (parents, children, siblings)
* Normal functional behavior in terms of daily activities, based on the Functional Activities Scale In line with recommendations of the SCD task force an informant must be available for two reasons: a) to provide information about the participant's cognition using the informant version of the CDR and CCI-20, and b) to corroborate normal IADL's on the Functional Activity Questionnaire (informant data will be collected via a phone call and linked by code with the participant data).

Exclusion criteria

* If participants score less than 21 on the Telephone Interview for Cognitive Status (TICS)
* Significant medical event requiring hospitalization in the past 6 months that has the potential to contaminate data being collected (fracture, hospitalization etc.)
* Severe visual impairment or corrected visual acuity less than 20/40 (as per self-report), which would preclude completion of assessments
* Inability to undergo MRI brain imaging due to claustrophobia or implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics, certain non-removable body jewelry, or shrapnel containing ferromagnetic metal
* History of severe stroke
* Epilepsy or family history of epilepsy, past seizure history, as well as history of migraines
* Current use of psychotropic medications
* Any major ADL disability (unable to feed, dress, bath, use the toilet, or transfer)
* Report of lower extremity pain due to osteoarthritis that significantly limits mobility
* Diagnosis or treatment for rheumatoid arthritis
* Known neuromuscular disorder or overt neurological disease (e.g., Multiple Sclerosis, Rhabdomyolysis, Myasthenia Gravis, Ataxia, Apraxia, post-polio syndrome, mitochondrial myopathy, Parkinson's Disease, ALS etc.)
* Unable to communicate because of severe hearing loss or speech disorder
* Planned surgical procedure or hospitalization in the next 4 months (joint replacement, coronary artery bypass graft, etc.)
* Severe pulmonary disease, requiring the use of supplemental oxygen
* Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, recent history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
* Use of walker or wheelchair

Where it's running

• University of Florida
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Rachael C. Seidler — University of Florida
• Study coordinator: Alyssa Hayes
• Email: alyssa.hayes@ufl.edu
• Phone: (352) 273-2134

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Daily-life Virtual Reality Training to Support Thinking and Daily Tasks in adults 50 and older

  A touchscreen-based daily-life VR program is being tested to see if it helps people 50+ improve daily activities and thinking skills, especially for those at risk of dementia.

  Recruiting National Taiwan University Hospital · Taipei · NCT07895979

• Aging Brain Health Initiative in Fujian

  This observational study will follow about 3,000 older adults in Fujian to see how Alzheimer's-related changes develop and to test new digital tests, biomarkers, and imaging tools for early diagnosis.

  Recruiting at 4 sites Fujian Medical University Union Hospital · Fushun, Fujian and 3 other locations · NCT07891429

• Longitudinal profiling of plasma-derived glial extracellular vesicles in Alzheimer's disease

  This study tests whether plasma glial extracellular vesicles and neuroinflammation biomarkers change over time across the Alzheimer’s disease spectrum and whether these signals relate to amyloid, tau, and neurodegeneration, with an additional step of exposing healthy iPSC-derived neurons to vesicles to see potential ne

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Rome · NCT07803055

• Digital tools to predict Alzheimer's biology from risk factors

  This study tests a digital, AI-based tool that analyzes modifiable and non-modifiable risk factors to see if it can predict biological changes linked to Alzheimer's disease in adults with MCI or SCD.

  Recruiting at 2 sites IRCCS Centro San Giovanni di Dio Fatebenefratelli · Brescia, BS and 1 other locations · NCT07731191

• Personalized Brain Health Service for Dementia Prevention in People with Subjective Cognitive Decline

  This study tests a personalized Brain Health Service to see if tailored risk assessment and a 6‑month lifestyle program can lower dementia risk for people aged 55–85 who have subjective cognitive concerns.

  Recruiting Barcelonabeta Brain Research Center, Pasqual Maragall Foundation · Barcelona, Catalonia · NCT07698431

• Virtual reality-based cognitive and physical rehab for people with mild cognitive impairment or subjective cognitive decline

  This study tests whether VR-based cognitive and physical rehabilitation is feasible, usable, and acceptable for people with mild cognitive impairment or subjective cognitive decline.

  Recruiting The University of Texas Health Science Center, Houston · Houston, Texas · NCT07638748

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.