Active NIR-PBM for Alzheimer Disease

Phase-Based Estimates
1
Effectiveness
2
Safety
University of Florida McKnight Brain Institute, Gainesville, FL
Alzheimer Disease+2 More
Active NIR-PBM - Device
Eligibility
65+
All Sexes
Eligible conditions
Alzheimer Disease

Study Summary

This study is evaluating whether a light therapy may help improve cognitive function in older adults.

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Eligible Conditions

  • Alzheimer Disease
  • Cognitive Aging
  • Alzheimer Disease, Protection Against

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Active NIR-PBM will improve 1 primary outcome in patients with Alzheimer Disease. Measurement will happen over the course of Baseline; Week 12.

Baseline; Week 12
Change in Active group ARENA scores compared to Sham group ARENA scores

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Sham NIR-PBM
Active NIR-PBM
Placebo group

This trial requires 168 total participants across 2 different treatment groups

This trial involves 2 different treatments. Active NIR-PBM is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Active NIR-PBM
Device
For transcranial stimulation, the study team will use two MedX units (1116 Rehab Console, MedX Health), whereas intranasal stimulation is delivered using the 810 Intranasal device (Vielight Inc). During each lab session, six transcranial LED clusters will be placed on the scalp in two distinct configurations guided by 10-20 EEG system. Total transcranial stimulation time is 40 minutes, 20 min per cluster. Concurrently, two 810 intranasal devices will be placed in each nostril for 25 min of total dose per nostril. For at home sessions, participants will use the standalone 810 Intranasal device only. Total amount of sessions: 16 sessions of stimulation will occur in the laboratory. Each session will last approximately 90 minutes and will include two 20-minute segments of NIR stimulation. AND 44 sessions of intranasal stimulation in the home. Each session will last 25 minutes and will occur on weekdays when there is no in-lab session.
Sham NIR-PBM
Device
Participants randomized to the Sham control group will undergo identical procedures as the Active group. The only difference is that the "sham" NIR devices are modified not to deliver stimulation. Because NIR is invisible, participants are unable to detect whether NIR is being delivered.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline; week 12
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline; week 12 for reporting.

Closest Location

University of Florida McKnight Brain Institute - Gainesville, FL

Eligibility Criteria

This trial is for patients born any sex aged 65 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The study found that cognitive complaints were more common in older adults with a score of 16 or more on the Cognitive Change Index (CCI-20), which measures perceived cognitive change. show original
The individual has no evidence of dementia or mild cognitive impairment based on cognitive screening show original
According to the reading subtest of the Wide Range Achievement Test- IV, the person is reading at an 8th grade level or higher. show original
.5 The Global Clinic Dementia Rating (CDR) score must be 0.5 or higher in order for a person to be eligible for the Global Clinic Dementia program. show original
The text states that there is no evidence of cognitive impairment based on neuropsychological test scores from the NACC Unified Data Set show original
Seniors aged 65-89 years who have completed at least 8th grade education and live in the community are eligible for this study. show original
A person who has a family history of dementia or probable Alzheimer's disease in a first degree relative is at an increased risk for developing the disease show original
The study population was willing to be randomized to sham or active intervention. show original
Can spend 12 weeks on the program with additional time for pre- and post-testing. show original
The text is about how a person's daily activities are assessed based on the Functional Activities Scale show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of alzheimer disease?

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Signs of neurological deterioration include disorientation, confusion, agitation or aggression, and hallucinations. Dementia is always accompanied by behavioural changes. Dysarthria due to stroke is often found. Changes in sensory sensations are common in Alzheimer's disease. The signs of Parkinson's disease include slowness of movement with onset between 50 and 70 years of age in combination with symptoms such as tremors, bradykinesia or the gait ataxia that are symmetric and symmetrical in the onset. Many different types of dementia are found with Alzheimer's disease being the most commonly diagnosed. It is the cause of more than half of all cases of dementia.

Unverified Answer

What causes alzheimer disease?

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Genetic vulnerability together with environmental stressors may result in the onset of AD. Studies are beginning to demonstrate the role of diet, environment, and infections in the natural development of AD. Identifying the pathophysiology of these processes will be critical to understanding the pathogenesis of AD.

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How many people get alzheimer disease a year in the United States?

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The number of cases of Alzheimer’s disease diagnosed in U.S. hospitals has steadily increased for at least the last two decades. In 1997 more than 14,500 people in U.S. hospitals received an Alzheimer’s diagnosis for the first time.

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Can alzheimer disease be cured?

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There are a number of reasons why an Alzheimer's disease cure cannot be found, which are not all presently understood. In principle, many treatments are effective at improving quality of life before symptoms of dementia emerge. Although a significant number of therapies are used, there are no treatments which stop the disease process or prevent it from taking hold. A cure for Alzheimer's disease seems impossible.

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What is alzheimer disease?

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Alzheimer disease is one of the most common causes of dementia and is usually in elderly people. Symptoms vary, but include irritability, memory loss, and a change in personality. Patients may also develop a cough that worsens over time. Alzheimer disease has no cure, and current treatments are aimed at slowing the progression rather than preventing it altogether. It can be detected early by using medical tests to look for changes in the brain that accompany the gradual onset of dementia.

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What are common treatments for alzheimer disease?

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Many common treatments were used among our patients suffering from Alzheimer disease. This confirms the severity of the disease. Nevertheless, the number of medications taken was the most common cause of adverse effects. For patients suffering minor cognitive difficulties, an early start to drugs is worthwhile. If patients have [progressive] memory loss and/or cognitive decline, they should start with a single neuroactive medication such as an anxiolytic or antipsychotic drug as a first-line treatment.

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Is active nir-pbm typically used in combination with any other treatments?

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It was found that AD patients did not tolerate nir-Pbm alone as treatment. This finding may be explained by the high rate of hepatic toxicity observed. However, when nir-Pbm was incorporated into the treatment, it significantly improved the patient outcome as compared with no treatment.

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What are the common side effects of active nir-pbm?

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There are numerous common side effects associated with active nir-pbm and the common symptoms are mostly mild and self-limiting. These symptoms are easily monitored and managed. Side effects of the active formulation (injection) are mostly injection-related like itching, burning, bruising, bruising in arm or leg, redness, swelling, feeling tired, dizziness and headache as well as allergic reactions.

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Have there been any new discoveries for treating alzheimer disease?

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We summarize a number of intriguing recent findings that have been reported in peer-reviewed scientific journals, of which several will be considered for this article.

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What is the latest research for alzheimer disease?

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This article should help doctors and patients know what evidence shows for and against treatments and the risk of Alzheimer's disease and related illnesses. Since Alzheimer's disease is so difficult to treat, you may look for clinical trials to try something new and maybe benefit your patient.\n

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Does alzheimer disease run in families?

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Findings from a recent study provides convincing evidence that people in families who have AD are more likely to develop AD than those in families without a history of AD. The finding supports the existence of a familial liability. Findings from a recent study suggest that the risk of developing AD is enhanced by having the mutated gene within family members.

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Is active nir-pbm safe for people?

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Active nir-pbm has been developed and licensed by the Canadian Pulsar Watch Group (the group that coordinates the National Radiation Oncology Conference) and the Canadian Coalition for Radiation Oncology with The Health Protection and Compensation Act of 2004 (H.P.C.A.) as a "safe" therapy for people with radiation-sensitive cancers using stereotactic radiation therapy. This paper will focus only on nir-pbm's safety in people with Alzheimer's disease. Results from a recent paper of a five-year pilot study published in the journal "Neurosurgery" (April 23, 2018) showed no difference in death rates in people with Alzheimer's disease and those who had received radiation therapy.

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