Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients

NCT05016219 · View on ClinicalTrials.gov ↗

Study Summary

Participants will randomly be placed into one of four groups and experience one of the four following conditions: (1) a placebo light that provides a 40 hertz (Hz) flicker (rhythmic light \[RL\]); (2) a placebo light with a random flicker (placebo condition for rhythmic light); (3) a light source that will stimulate the circadian system and provides a 40 Hz flicker (RL); or (4) a light source that will stimulate the circadian system and provides a random flicker (placebo condition for rhythmic light). Following a baseline week, participants will experience his/her assigned lighting condition for two hours in the morning for 8 weeks. After a 4-week washout period, a final round of assessments will be obtained. Study assessments (except for the Pittsburgh Sleep Quality Index and Montreal Cognitive Assessment) will be collected at the end of each week, for a total of 8 assessments.

Conditions Studied

Interventions

  • DEVICE Circadian-Effective Light
  • DEVICE Rhythmic Light
  • DEVICE Placebo Light
  • DEVICE Placebo Rhythmic Light

Study Locations (2)

New York

  • Light and Health Research Center — Menands
  • Icahn School of Medicine at Mount Sinai — New York

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2023-08-22
Est. Completion 2027-07-31
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05016219

The ClinicalTrials.gov registry entry for NCT05016219 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 946 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 4 interventions — of which Circadian-Effective Light is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05016219 reports 2 study locations spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05016219 about?

NCT05016219 is a clinical study titled "Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients". Participants will randomly be placed into one of four groups and experience one of the four following conditions: (1) a placebo light that provides a 40 hertz (Hz) flicker (rhythmic light \[RL\]); (2) a placebo light with a random flicker (placebo condition for rhythmic light); (3) a light source th...

What is the current status of trial NCT05016219?

This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2023-08-22. Estimated completion is 2027-07-31.

What conditions does trial NCT05016219 study?

This clinical trial studies the following conditions: Mild Cognitive Impairment. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05016219?

The interventions under investigation include: Circadian-Effective Light (DEVICE), Rhythmic Light (DEVICE), Placebo Light (DEVICE), Placebo Rhythmic Light (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05016219?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 946 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05016219 being conducted?

This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial