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NCT03543878: FLICKER

Stimulating Neural Activity to Improve Blood Flow and Reduce Amyloid: Path to Clinical Trials

Completed NA Results posted Last updated 2 March 2021
What this trial tests

NA trial testing Flicker in Alzheimer Disease in 10 participants. Completed in 10 February 2020.

Timeline
16 November 2018
Primary endpoint
10 February 2020
10 February 2020

Quick facts

Lead sponsorEmory University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposesupportive care
Enrollment10
Start date16 November 2018
Primary completion10 February 2020
Estimated completion10 February 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Emory University

Who can join

Adults 50 to 90, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Adherence to Daily Device Use Primary · Week 8

Feasibility of the Flicker intervention is defined as adherence to Flicker exposure, at home, for one hour per day for the duration of the intervention period (4 or 8 weeks). The percentages of completed sessions are presented here.

GroupValue95% CI
Flicker/Flicker95.55± 2.92
No Flicker/Flicker95.37± 4.72
Percentage of Maximum Tolerated Stimulation Primary · Baseline

Participants rated their tolerance to Flicker stimulation prior to the study intervention, using a 1 - 5 point Likert scale for each of the 10 levels of brightness (visual stimulation) and each of the 10 levels of loudness (auditory stimulation) after 60 seconds of stimulation at each level. A rating of 1 indicated stimulation "can be withstood and comfortable," 3 indicated stimulation is "tolerable, but not necessarily comfortable," and 5 indicated stimulation "cannot be withstood or is uncomfortable." Ratings of 1, 2, and 3 were considered tolerable. After determining tolerance for auditory

Visual alone
GroupValue95% CI
All Study Participants94± 9.66
Auditory alone
GroupValue95% CI
All Study Participants98± 4.22
Visual when combined with auditory
GroupValue95% CI
All Study Participants93± 12.52
Auditory when combined with visual
GroupValue95% CI
All Study Participants94± 18.97

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Flicker/Flicker
Serious: 0/5 (0%)
Deaths: 0/5
No Flicker/Flicker
Serious: 0/5 (0%)
Deaths: 0/5
Other adverse events (13 terms — click to expand)

ReactionSystemFlicker/FlickerNo Flicker/Flicker
Back painMusculoskeletal and connective tissue disorders
DizzinessGeneral disorders
TinnitusEar and labyrinth disorders
HeadacheGeneral disorders
Double visionGeneral disorders
Leg, arm, joint painMusculoskeletal and connective tissue disorders
DepressionPsychiatric disorders
RhinorrheaGeneral disorders
Gastrointestinal problemsGeneral disorders
FallInjury, poisoning and procedural complications
Dog biteInjury, poisoning and procedural complications
Skin growth on neckNeoplasms benign, malignant and unspecified (incl cysts and polyps)
HemorrhoidsGastrointestinal disorders

Data from ClinicalTrials.gov NCT03543878 adverse events section.

Sponsor's own description

Alzheimer's disease is characterized by the accumulation of toxic proteins in the brain. Mechanisms to remove these proteins have been the target of many drug trials. This study is designed to use a device to entrain brain waves to a specific frequency to see if rodent research can be replicated in humans with mild cognitive impairment. Ten participants will be recruited from the Emory Alzheimer's Disease Research Center (ADRC) database and assigned to either treatment for 8 weeks or treatment for 4 weeks. This latter group will serve as the control group (4 weeks no treatment, 4 weeks treatment). It is hypothesized that exposure to the gamma oscillations (Flicker) will clear toxic proteins from the brain and increase cerebral blood flow.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Alzheimer's disease drug development pipeline: 2019.
    Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2019 · cited 485× · PMID 31334330 · DOI 10.1016/j.trci.2019.05.008
  2. A feasibility trial of gamma sensory flicker for patients with prodromal Alzheimer's disease.
    He Q, Colon-Motas KM, Pybus AF, Piendel L, et al · · 2021 · cited 95× · PMID 34027028 · DOI 10.1002/trc2.12178
  3. Therapy for Alzheimer's disease: Missing targets and functional markers?
    Stoiljkovic M, Horvath TL, Hajós M. · · 2021 · cited 52× · PMID 33711510 · DOI 10.1016/j.arr.2021.101318
  4. CSF proteomics reveals changes in myelin and synaptic biology after Spectris treatment.
    Hajós M, Pandey K, Singer AC, Duong D, et al · · 2025 · cited 2× · PMID 39935616 · DOI 10.1002/trc2.70051
  5. Sensory evoked gamma oscillation reduces white matter loss and preserves myelin in Alzheimer's disease: neuroimaging and proteomics findings
    Hajos M. · · 2025
  6. The Potential for Neuromodulation in the Treatment of Alzheimer's Disease: A Review of Clinical Trials.
    Jones T, Shalom M, Chalamgari A, Gold J, et al · · 2025 · PMID 40599507 · DOI 10.7759/cureus.85156
  7. Time saved in activities of daily living and whole-brain volume: Post hoc analysis of a randomized feasibility trial of gamma oscillation treatment in participants with mild or moderate Alzheimer's disease.
    Kern R, Haaland B, Nicodemus-Johnson J, Dickson S, et al · · 2025 · PMID 40501511 · DOI 10.1002/trc2.70118
  8. Mechanistic Insights of Gamma Sensory Stimulation: CSF Proteomic Analyses Reveal Changes in Myelin and Synaptic Proteins
    Shpokayte M, Pandey K, Singer A, Doung D, et al · · 2024

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