N/A N=20 Randomized Treatment

Photobiomodulation for Improving Brain Function in Dementia (PBM Dementia)

Dementia, Alzheimer Type

Bottom Line

View on ClinicalTrials.gov: NCT03160027 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: Change in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog) — 5.8; -7.2; 4.8 units on the ADAS-cog scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Vielight Neuro Gamma (Device)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Sep 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog)	5.8; -7.2; 4.8	—
PRIMARY Change in Clock-drawing Test	0.3; 0.5; 0	—
PRIMARY Change in Default Mode Network (DMN) Functional Connectivity	4.25; 6.88; 14.15; 3.86; 3.98; 8.34	—
PRIMARY Change in Arterial Spin Labeled (ASL) Perfusion MRI Measure	0.89; 1.20; 1.22; 0.91	—
PRIMARY Change in Quality of Life Scale in Alzheimer's Disease (QOL-AD)	1.5; -0.3; 3	—
SECONDARY Change in QOL-AD From the Caregiver's Perspective About the Individual With Dementia	1.8; 3.8; -2.3	—
SECONDARY Change in Caregiver Burden Inventory (CBI).	12.0; -7.8; -2.5	—
SECONDARY Change in Neuropsychiatric Inventory (NPI)	17.8; -2.0; 6.7	—
SECONDARY Change in Positive Aspects of Caregiving Scale	0.3; 0.0; -0.3	—
SECONDARY Change in Geriatric Depression Scale (GDS) - Short Form in the Caregivers	-0.3; 0.0; -0.3	—

Summary

A recent study (Saltmarche et al., 21017) examined the effects of photobiomodulation (PBM), a kind of light therapy that uses red or near-infrared light to heal and protect tissue that has either been injured, is degenerating, or else is at risk of dying, in 5 older adults with dementia. After 12 weeks of PBM treatments, delivered with a commercially available, wearable device, the patients with mild to moderately severe dementia showed improvements on the Mini-mental State Exam (MMSE, p<0.003) and Alzheimer's Disease Assessment Scale-cognitive, ADAS-cog, p<0.03). The caregivers, who kept daily journals of their experiences during the 12 weeks of PBM treatment, reported better sleep, fewer angry outbursts, decreased anxiety and wandering in their loved-ones with dementia. The goals of this trial are to: (1) replicate this finding in a larger group of individuals with dementia and (2) to examine the underling brain mechanisms behind the changes in cognitive function.

Eligibility Criteria

Inclusion Criteria

For primary study participants (i.e., individuals with dementia):

age > 50 years a diagnosis of dementia (preferably AD) by their neurologist English language fluency, legally authorized representative consent no contraindications for MRI MMSE > 11

Inclusion criteria for caregivers:

current provision of care to primary participant with dementia ability to answer questions about the primary participant's behaviors, quality of life, and their own level of stress.

Exclusion Criteria

For primary study participants (i.e., individuals with dementia):

lack of assent to study procedures contraindications for MRI (i.e., pacemakers, metal implants, claustrophobia) terminal illness (i.e., life expectancy < 1 year) started dementia medication (i.e., cholinesterase inhibitor or memantine) in the past 3 months or planning to start new dementia medication current participation in another research study that could potentially confound current study (e.g., medication or behavioral intervention) MMSE < 11.

Exclusion criteria for caregivers:

major neurological or psychiatric condition terminal illness evidence of cognitive impairment inability to consent to study procedures

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03160027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.