CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 91 enrolled
Drug / intervention
LLLT +1 moredevice
Likely dose
1064 nm laser via CG-5000 laser deviceAI-extracted
Key inclusion· 3
  • Men and postmenopausal women
  • Age 45 years or older
  • Diagnosed with Mild Cognitive Impairment or cognitively healthy
Key exclusion· 4
  • Neurological disease including stroke, seizure, Parkinson's, Alzheimer's, traumatic brain injury with loss of consciousness >30 minutes, multiple sclerosis, or brain infection/meningitis
  • Baseline IQ below 85
  • Major psychiatric illness (schizophrenia, bipolar disorder) or substance abuse
  • Severe cardiovascular disease (including pacemaker), COPD, liver or kidney disease, or inflammatory illness

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02851173
NCT02851173Phase 2Completed

Cognitive Enhancement Through Transcranial Laser Therapy

University of Texas at Austin·interventional·Posted Aug 1, 2016·Updated Oct 4, 2023

In Brief

A Phase 2 clinical trial evaluating LLLT and Placebo for Healthy Participants and Mild Cognitive Impairment. Completed, enrolled 91 participants across 1 site.

Detailed Summary

This is a mechanism-driven translational project to test the efficacy of transcranial low-level light/laser therapy (LLLT), for enhancing cognitive function in middle-aged and older adults and participants with Mild Cognitive Impairment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 1, 2016
Enrollment StartFeb 21, 2016
Primary CompletionApr 30, 2020
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 9.9 years ago

Interventions

LLLTdevice

The treatment will consist of applying light of a specific wavelength (1064 nm) using a laser diode supplied by Cell Gen Therapeutics, LLC (CG-5000 laser, HD Laser Center, Dallas, TX, USA).

Placebodevice

The treatment will consist of applying light of a specific wavelength (1064 nm) using a laser diode supplied by Cell Gen Therapeutics, LLC (CG-5000 laser, HD Laser Center, Dallas, TX, USA). However, the placebo group will receive approximately 1/12th of the cumulative energy density as the treatment group.