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NCT05016219 · ClinicalTrials.gov registry record · NA
Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients
A NA study of Mild Cognitive Impairment, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 2
- Study locations
NCT05016219: Recruiting NA study of Mild Cognitive Impairment, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05016219 is a NA study of Mild Cognitive Impairment that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 120 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05016219, a NA study of Mild Cognitive Impairment, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
The Montreal Cognitive Assessment is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function.
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
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-08-22 |
| Est. Completion | 2027-07-31 |
| Phase | NA |
What NCT05016219 shows while recruiting
NCT05016219 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (91% lower).
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.
NCT05016219 reports a single indexed study location in New York.
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.
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).
Who is sponsoring clinical trial NCT05016219?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05016219's enrollment target sits among peer trials
120 79th of 205 higher than 122 of 205 other Mild Cognitive Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Cognitive Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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