Clinical trial NCT04496778: Low Level Laser Therapy Impact on Cognitive Function and Quality of Life in Alzheimer Anemic Elderly Patients
Official title: The Beneficial Effect of Low Level Laser Therapy Combined With Nasal Irradiation on Cognitive Function and Quality of Life in Alzheimer Anemic Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Cognitive Impairment, Mild
Keywords: low level laser
quality of life
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Alzheimer's is a type of dementia that affects memory, thinking and behavior. Symptoms eventually grow severe enough to interfere with daily tasks. this study aimed to delay the deterioration of anemic elderly condition as memory affection interfere with daily life activities and social interaction

Detailed description: Alzheimer's disease is the commonest cause of dementia and describes a clinical syndrome made up of three domains. First, a neuro-psychological domain encompassing those deficits of cognitive function such as amnesia (memory loss), aphasia (language disturbance), apraxia (the inability to carry out motor tasks despite intact motor functions) and agnosia (the inability to recognize people or objects despite intact sensory functions). Second, a group of psychiatric symptoms and behavioral disturbances, which have been termed neuro-psychiatric features, non-cognitive phenomena, or behavioral and psychological symptoms of dementia Alzheimer's disease is substantially increased among people aged 65 years or more, with a progressive decline in memory, thinking, language and learning capacity. Alzheimer's disease should be differentiated from normal age-related decline in cognitive function, which is more gradual and associated with less disability. Diabetes, hypertension, smoking, obesity, and dyslipidemia have all been found to increase risk as well a history of brain trauma, cerebrovascular disease, and vasculopathies.

Dementia affects approximately 5%-8% of individuals over age 65, 15%- 20% of individuals over age 75, and 25%-50% of individuals over age 85. Alzheimer disease is the most common dementia, accounting for 50%-75% of the total, with a greater proportion in the higher age ranges Dementia is expensive. The financial costs of managing Alzheimer's disease are enormous. The cost of illness is high in terms of both public and private resources. Families and caregivers who are required to provide care and patients affected by dementia also pay a high price in terms of their quality of life The primary goals of treatment are to maximize the patient's ability to function in daily life, maintain quality of life, slow the progression of symptoms, and treat depression or disruptive behaviors Low level laser therapy is a safe, non-invasive, and non-thermal modality that is based on a strong body of research dating back to the 1960.It involved in treating several conditions, the mechanisms of action involve the stimulation of mitochondria by the absorption of photons in cytochrome c oxidase, resulting in increased adenosine triphosphate production, reduced oxidative stress, anti-inflammatory effects, and increased focal cerebral blood flow

Eligibility criteria: Inclusion Criteria:

* Sixty elderly patients aged from 65-75 y
* Body mass index (BMI) ranged from 30 to 34.9 kg/m2
* Mild cognitive dysfunction (Montreal cognitive assessment scores from 19-25
* Anemic
* The time between their diagnoses and participation in the study ranged from 6 months to 2 years

Exclusion Criteria:

* Moderate to severe cognitive impairment
* History of neurological disease ,stroke or Cardiovascular disease
* History of nasal bleeding or fracture
* Known photo-sensitivity disorder
* Current active cancer or within one year of cancer treatment or remission
* Serious mental health illness that in the opinion of the investigator would preclude the subject from study participation
* Active infection, wound or other external trauma to the target area to receive the laser therapy
* Participation in a clinical study or other type of research in the past 30 days

Primary outcomes:
measure: change of cognitive function
timeFrame: 3 months
measure: changes of hemoglobin level
timeFrame: 3 months
measure: changes of balance
timeFrame: 3 months
measure: changes of quality of life
timeFrame: 3 months
Secondary outcomes:
measure: changes of body mass index
timeFrame: 3 months
measure: changes of waist hip ratio
timeFrame: 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo
state: Dokki
Study officials:
affiliation: Cairo University
name: Ebtesam Nabil, doctoral
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nagy EN, Ali AY, Behiry ME, Naguib MM, Elsayed MM. Impact of Combined Photo-Biomodulation and Aerobic Exercise on Cognitive Function and Quality-of-Life in Elderly Alzheimer Patients with Anemia: A Randomized Clinical Trial. Int J Gen Med. 2021 Jan 14;14:141-152. doi: 10.2147/IJGM.S280559. eCollection 2021.