Alzheimer DiseaseNCT04496778
Low Level Laser Therapy Impact on Cognitive Function and Quality of Life in Alzheimer Anemic Elderly Patients
A study testing low level laser therapy ( laser acupuncture combined with nasal laser irradiation) and aerobic exercise in people with Alzheimer Disease and Cognitive Impairment, Mild, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Alzheimer Disease, Cognitive Impairment, Mild
- What is being tested?
- low level laser therapy ( laser acupuncture combined with nasal laser irradiation) and aerobic exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2020to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Alzheimer Disease, Cognitive Impairment, Mild
- Being tested
- low level laser therapy ( laser acupuncture combined with nasal laser irradiation), aerobic exercise
- Keywords
- low level laser, quality of life
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser therapy ( laser acupuncture combined with nasal laser irradiation)Device
Cold Laser Therapy Watch (Laser Watch- 650 nm) combines acupuncture and nasal cavity for external blood irradiation. Laser watch with 10 laser beams - is applied to the left wrist.
Nasal Probe with 2 laser beams - is applied to the nose cavity
aerobic exerciseOther
3 d/week for 45 to 60 minutes per session for 3 months. started by 40%-50% Heart Rate Reserve (determined by using a walking treadmill exercise test) during the first 6 weeks increasing gradually up to 50%-70% Heart Rate Reserve
| Study group | Role | What they receive |
|---|---|---|
| low level laser plus exercise | Active comparator | acupuncture low level laser combined with nasal laser irradiation in addition to aerobic exercise 3 times per week for 3 months Receives: Device: low level laser therapy ( laser acupuncture combined with nasal laser irradiation); Other: aerobic exercise |
| sham laser plus exercise | Placebo comparator | placebo acupuncture low level laser combined with nasal laser irradiation in addition to aerobic exercise 3 times per week for 3 months Receives: Device: low level laser therapy ( laser acupuncture combined with nasal laser irradiation); Other: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of cognitive function
comparison of Montreal assessment scale scores before and after the intervention It range between 0 and 30. A score of 26 or over is considered to be normal.
Measured: 3 months
changes of hemoglobin level
comparison of hemoglobin level for those anemic elderly before and after the intervention
Measured: 3 months
changes of balance
comparison of berg balance scale scores before and after the intervention. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function
Measured: 3 months
changes of quality of life
comparison of quality of life for Alzheimer disease scores before and after the intervention. It comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole) for a total score of 13-52 with higher scores indicating better quality of life
Measured: 3 months
Secondary outcomes (2)
changes of body mass index
comparison of body weight (kilogram) before and after the study in relation to height per meter square (weight and height will be combined to report BMI in kg/m^2)
Measured: 3 months
changes of waist hip ratio
changes of waist hip ratio before and after the study
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start3 Jan 2020
- Primary completion28 Jul 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebtesam Nabil, Cairo University
- Investigators
- Ebtesam Nabil, doctoral, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496778
- Sponsor's protocol ID
- P.T.REC/012/0027772
- Status last verified
- Aug 2020
- First submitted
- 27 Jul 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 33469351
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04496778
- Acronym / sponsor ID
- P.T.REC/012/0027772
- Conditions
- Alzheimer Disease, Cognitive Impairment, Mild
- Keywords
- low level laser, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low level laser plus exercise | Active comparator | Device: low level laser therapy ( laser acupuncture combined with nasal laser irradiation), Other: aerobic exerciseacupuncture low level laser combined with nasal laser irradiation in addition to aerobic exercise 3 times per week for 3 months |
| sham laser plus exercise | Placebo comparator | Device: low level laser therapy ( laser acupuncture combined with nasal laser irradiation), Other: aerobic exerciseplacebo acupuncture low level laser combined with nasal laser irradiation in addition to aerobic exercise 3 times per week for 3 months |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low level laser therapy ( laser acupuncture combined with nasal laser irradiation)Cold Laser Therapy Watch (Laser Watch- 650 nm) combines acupuncture and nasal cavity for external blood irradiation. Laser watch with 10 laser beams - is applied to the left wrist. Nasal Probe with 2 laser beams - is applied to the nose cavity | Device | low level laser plus exercise, sham laser plus exercise |
| aerobic exercise3 d/week for 45 to 60 minutes per session for 3 months. started by 40%-50% Heart Rate Reserve (determined by using a walking treadmill exercise test) during the first 6 weeks increasing gradually up to 50%-70% Heart Rate Reserve | Other | low level laser plus exercise, sham laser plus exercise |
Primary outcome
change of cognitive function
Time frame: 3 months
comparison of Montreal assessment scale scores before and after the intervention It range between 0 and 30. A score of 26 or over is considered to be normal.
changes of hemoglobin level
Time frame: 3 months
comparison of hemoglobin level for those anemic elderly before and after the intervention
changes of balance
Time frame: 3 months
comparison of berg balance scale scores before and after the intervention. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function
changes of quality of life
Time frame: 3 months
comparison of quality of life for Alzheimer disease scores before and after the intervention. It comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole) for a total score of 13-52 with higher scores indicating better quality of life
2 secondary outcomes
changes of body mass index
Time frame: 3 months
changes of waist hip ratio
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Derived from this study: PubMed 33469351Nagy 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebtesam Nabil, doctoral principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low level laser therapy ( laser acupuncture combined with nasal laser irradiation) and aerobic exercise in people with Alzheimer Disease and Cognitive Impairment, Mild, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of cognitive function (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04496778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.