An Evaluation of Low Level Laser Light Therapy on Improving the Symptoms of Alzheimer's Disease

NCT02537626 | Completed

• 1 other identifier: EC_AD_001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the effect of applying low level laser light therapy to individuals with mild to moderate Alzheimer's disease to see if it may improve their memory, thinking and behaviors. Half of the participants will receive the real treatment with the laser device and the other half of the participants will receive a placebo treatment (not active laser).

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score

  The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) is a validated psychometric instrument to evaluate the following aspects of cognitive function: memory, attention, reasoning, language, orientation, ideational praxis and constructional praxis. Scores on the ADAS-cog range from 0-70 with higher scores indicating greater impairment. Therefore, a decrease in the ADAS-cog score from baseline to study endpoint indicates improved cognitive functioning and is positive for study success; whereas an increase in the ADAS-cog score from baseline to study endpoint reflects potential cognitive deterioration and is negative for study success. The minimal clinical important difference (MCID) on the ADAS-cog has been established as a 4 point change (decrease).

  4 months

• Alzheimer's Disease Co-Operative Study-Activities of Daily Living Inventory (ADCS-ADL)

  The Alzheimer's Disease Co-Operative Study-Activities of Daily Living Inventory (ADCS-ADL) is a validated tool to assess instrumental and basic activities of daily living (i.e. functional performance) of AD based on a structured interview of the study partner. Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; Therefore, an increase in the ADCS-ADL score from baseline to study endpoint indicates improved functioning and is positive for study success; whereas a decrease in the ADCS-ADL score from baseline to study endpoint reflects potential functional deterioration and is negative for study success. The minimal clinical important difference (MCID) on the ADAS-ADL has been established as a 2 point change (increase - improvement).

  4 months

Secondary Outcomes (2)

• Mini Mental State Examination (MMSE)

  4 months

• Study Partner Satisfaction With Overall Outcome Rating

  4 months

Study Arms (2)

Erchonia ALS Laser

ACTIVE COMPARATOR

The Erchonia ALS Laser is a mains powered variable hertz laser device made up of five independent red laser diodes mounted in scanner devices and positioned equidistant from each other. Each scanner emits 7.5 milliwatts (mW) ± 1.0 mW 640 nanometers (nm) with a tolerance of ±10 nm of red laser light.

Device: Erchonia ALS Laser

Placebo Laser

PLACEBO COMPARATOR

The Placebo Laser is identical in appearance and operation to the Erchonia ALS Laser but does not emit any therapeutic light.

Device: Placebo Laser

Interventions

Erchonia ALS Laser DEVICE

The Erchonia ALS Laser is administered to the subject's frontal cortex, temporal regions and base of the skull 8 times across 4 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration. The total energy delivered to the subject per procedure administration is 22.5 joules.

Erchonia ALS Laser

Placebo Laser DEVICE

The Placebo Laser is administered to the subject's frontal cortex, temporal regions and base of the skull 8 times across 4 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration. There is no energy delivered to the subject.

Placebo Laser

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient AD individual with consistent, reliable caregiver willing and able to participate as needed for the duration of the study
• Subject satisfies the Diagnostic and Statistical Manual Of Mental Disorders. 5th Edition (DSM-V) Criteria For Major Neurocognitive Disorder (NCD) Due To Alzheimer's Disease
• Mini-Mental Status Examination (MMSE) score of \> 11 to \< 26
• Hachinski ischemic score of ≤ 4
• The subject/study partner agrees to report any changes in medication use to the investigator throughout study duration
• to 85 years of age, inclusive
• Subject is ambulatory with or without aid
• Vision and hearing sufficient to comply with testing
• Normal cognitive and social functioning prior to onset of dementia
• Female subjects of child-bearing potential are willing and able to use acceptable means of contraception throughout study participation.
• English speaking subject and study partner

You may not qualify if:

• AD individual residing in an inpatient care facility, such as a nursing home
• Likelihood, according to clinical judgment, of being transferred to an inpatient care facility within 6 months
• Life expectancy is less than 6 months
• Non-Alzheimer primary dementia or neurodegenerative disease other than AD, including: vascular dementia; Lewy body dementia; fronto-temporal dementia; multi-infarct dementia; vitamin B-12 deficiency; hypothyroidism; Huntington's Disease; Parkinson's Disease; normal pressure hydrocephalus; cognitive dysfunction due to cerebral damage resulting from a lack of oxygen, a brain injury; cerebral tumor
• Autoimmune disorder, such as HIV, Chronic Fatigue Syndrome and fibromyalgia that in the opinion of the investigator is significant enough to affect the subject's ability to take part in all of the requirements of study participation
• Active cancer or treatment for cancer within the last 6 months
• Unstable cardiac disease, such as a recent cardiac arrhythmias (including atrial fibrillation, ventricular fibrillation and irregular atrial-ventricular conduction time), or recent congestive heart failure, or recent myocardial infarction
• Uncontrolled diabetes
• Known or diagnosed major depressive disorder, schizophrenia, or other significant psychotic disorders, bipolar disorder, or substance (including alcohol and/or drug) related disorders that in the opinion of the investigator may interfere with or affect study outcome evaluation; including hospitalization for psychiatric disturbances within the past 2 years
• Total score of 20 or greater on the Geriatric Depression Scale
• Any other advanced, severe, progressive, unstable and/or uncontrolled systemic disease or illness of any type that in the opinion of the investigator may interfere with study procedure administration and efficacy assessment
• Active infection, wound or other external trauma to the areas to be treated with the laser
• Medical, physical, or other contraindications for, or sensitivity to, light therapy
• Subject is presently pregnant, breast feeding or attempting or planning to attempt to become pregnant during the course of the study participation time frame
• Participation in a research study within the past 30 days

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (2)

Pruebas Clinicas

Zapopan, Jalisco, 45110, Mexico

Location

Neocemod

La Plazuela, Pocitos AGS, 20926, Mexico

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Leon Morales-Quezada, MD

  Neocemod

  PRINCIPAL INVESTIGATOR

• Andrew Campbell, MD

  Pruebas Clinicas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 1, 2015
• Study Start: March 15, 2018
• Primary Completion: June 15, 2020
• Study Completion: October 15, 2020
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)