An Evaluation of Low Level Laser Light Therapy on Improving the Symptoms of Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

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).
    

Detailed 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.
    

Intervention name(s): Erchonia ALS Laser; Placebo Laser
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment