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

Alzheimer's Disease Clinical Trial

Official title: An Evaluation of the Effect of the Erchonia ALS on Alzheimer's Disease

Status Completed

Clinical Trial 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).

Clinical Trial Description

Alzheimer's disease (AD) is a progressive type of dementia that causes problems with memory, thinking and behavior that gradually worsen over time. With an aging population, AD is an escalating problem, currently affecting an estimated 35 million people worldwide, with this number expected to grow to 65 million by 2030 and over 115 million by 2050. It is the sixth leading cause of death in the United States.

AD is a fatal degenerative disease of the brain that causes brain cells to die which as a result causes the memory failure, personality changes, problems carrying out daily activities and other symptoms associated with AD. AD is thought to be caused by an excess of beta amyloid (β-amyloid), a sticky protein in the brain that forms amyloid plaques and tangles that accumulate over time, and are associated with significant loss of neurons and synaptic activity in the brain.

Patients with AD typically first present with impaired memory and language dysfunction, with visuospatial dysfunction, impaired ability with calculations and complex tasks, behavioral and/or psychiatric symptoms developing as the disease progresses. The most common signs and symptoms of AD as the disease progresses are: memory loss that disrupts daily life, challenges in planning or solving problems, difficulty completing familiar home, work or leisure tasks, confusion with time or place, difficulty understanding visual images and spatial relationships, new problems with words in speaking or writing, misplacing things and losing the ability to retrace steps, decreased or poor judgment, withdrawal from work or social activities, changes in mood, personality and behavior.

There is presently no cure for Alzheimer's disease or its progression. Current available treatments can help to lessen or stabilize symptoms for a limited period of time. The FDA has approved two types of medications to treat the cognitive symptoms (memory loss, confusion, and problems with thinking and reasoning) of AD: cholinesterase inhibitors such as Aricept, Exelon, Razadyne, Cognex and memantine (Namenda). Side effects include nausea, dizziness, confusion, vomiting, headache, loss of appetite, constipation, increased frequency of bowel movements, and possible liver damage. Current alternative treatments include Vitamin E.

There are no medications approved specifically to treat behavioral and psychiatric AD symptoms. However, antidepressants; anxiolytics and antipsychotics are sometimes prescribed.

As currently available treatments for AD are minimal and of limited short-term effectiveness in mild symptom management at best, and have potentially serious associated side-effects, low level laser therapy is being evaluated in this study as a simple, non-invasive side-effect free alternate means of improving cognition and behavior symptoms in patients with mild to moderate AD.

The underlying condition of AD is the degeneration and death of nerve cells responsible for memory and cognition with identified genetic contributions. Application of low level laser therapy (LLLT), with its coherent emission of photons, has been shown to modulate cellular metabolism and alter the transcription factors responsible for gene expression to produce cell regeneration translating to a beneficial clinical effect. It is therefore hypothesized that through this mechanism, application of LLLT to individuals with AD will effect improvement in the expression of symptoms of AD. Prior Erchonia Corporation LLLT trials have shown beneficial clinical effects for other neurodegenerative and neurodevelopment disorders such as Parkinson's Disease and Autism Spectrum Disorder. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

• NCT number: NCT02537626
• Study type: Interventional
• Source: Erchonia Corporation
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Completion date: October 15, 2020