This arm will receive active photobiomodulation (PBM), delivered with the Vielight Neuro Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes for 16 weeks.

This arm will not receive active photobiomodulation (PBM). Instead, they will use a sham Vielight Neuro Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes for 16 weeks.

Alzheimer Disease

The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.

Vielight Neuro Gamma

The Sham Vielight Neuro Gamma headset is identical to the active Vielight Neuro Gamma headset and intranasal light emitting diode (LED) except it has a power output of 0.

Sham Vielight Neuro Gamma

VA Health Care System

UCSF Memory and Aging Center

Impact of Photobiomodulation (PBM) on Biomarkers of Alzheimer's Disease

Examining the Impact of Photobiomodulation on Cognition, Behavior, and Biomarkers of Alzheimer's Disease

The ADAS-cog is the most popular cognitive testing instrument used in clinical trials of nootropics. It consists of 11 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD.

CTTis a non-verbal test of visual attention, graphomotor sequencing, and effortful executive processing abilities (i.e., sustained attention and set shifting).

NPI is a well-validated, reliable, multi-item instrument to assess psychopathology (e.g., behavioral symptoms) in AD based on an interview with a study companion or qualified partner.

ADCS-ADL assesses the competence of patients with AD in basic and instrumental activities of daily living (ADLs). It can be completed by a caregiver in questionnaire format, or administered by a clinician/researcher as a structured interview with a caregiver.

MCP-1 is a biomarker of neuroinflammation.

UCH-L1 is a biomarker of neurodegeneration.

BDNF is a neurotrophic factor, which supports the growth, survival, and differentiation of both developing and mature neurons.

University of California, San Francisco

Participants randomized to the "Active PBM" group will use an active Vielight Neuro device, for 16 weeks, once every other day (e.g., Mon, Wed, Fri) for 20 minutes.
Participants randomized to the "Sham PBM" group will use a a sham Vielight Neuro device, for 16 weeks, once every other day (e.g., Mon, Wed, Fri) for 20 minutes.
All study participants will undergo cognitive and behavioral assessments, blood draw, and lumbar puncture at baseline (before using Vielight Neuro Gamma device) and after 16 weeks of using the Vielight Neuro Gamma device.
Upon completion of the post-16 week assessments, blood draw, and lumbar puncture, patients randomized to the Sham PBM group will be offered an opportunity to use an active Vielight Neuro Gamma device for 16 weeks. We will assess cognition and behavioral symptoms in Sham patients who opt to undergo active PBM 16 weeks after they start active PBM treatments.

Blind assignment determined by a computer-generated random allocation schedule

fluticasone inhaler, 88mcg (2 puffs), twice a day for 4 weeks + standard voice therapy

Vocal Fold Nodules

fluticasone inhaler 44mcg/puff, 2 puffs twice a day for 4 weeks

Fluticasone propionate

Standard voice therapy

Children's Hospital of Pittsburgh of UPMC

The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children

The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children: A Pilot Study

percent of prescribed doses marked as "taken" on diary

change in fundamental frequency from baseline to end of therapy

change in score from QOL questionnaire from baseline to end of therapy

change in time from baseline to end of therapy

change in ratio of 2 measures from baseline to end of therapy

Joseph Dohar, MD

Professor of Otolaryngology

15 subjects in each RT dose schedule 10 GY in 5 daily fractions 20 GY in 10 daily fractions

Alzheimer's Disease

10 GY in 5 daily fractions

Subjects 16-30 20 GY in 10 daily fractions

20 GY in 10 daily fractions

Virginia Commonwealth University

Low Dose RT to Reduce Cerebral Amyloidosis in Early Alzheimer's

Phase IIa Trial of Low Dose Radiation THerapy to Reduce Cerebral Amyloidosis in Early Alzheimer's Dementia

Evaluate the safety and toxicity/adverse events associated with the delivery of low dose fractionated whole brain irradiation in subjects with early Alzheimer's dementia using CTCAE Version 4.0 and the RTOG toxicity grading system

Patients will complete neurocognitive function tests which will be used to assess any neurocognitive changes, following treatment. Analysis will be completed by a neuropsychology specialist and will be preformed at 6 weeks, 3, 9, 12 months and compared to pretreatment results.

Analysis will be completed by a neuropsychology specialist and will be performed at 6 weeks, 3, 9, 12 months and compared to pretreatment results.

IVIG

Placebo

Total

Sex: Female, Male

Region of Enrollment

The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia. It is one of the most widely used cognitive scales in clinical trials and is considered to be the "gold standard" for assessing antidementia treatments. The ADAS-Cog range from 0 to 70, where higher scores indicate greater cognitive dysfunction.

ADAS-Cog

The Clinical Global Impression of Change focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of informants. Unlike a targeted symptom scale, it takes into account a subject's overall function in the cognitive, behavioral and functional activity domains. Scoring is based on an interview with the caregiver and examination of the patient by an independent evaluator, without consulting other information such as cognitive test results. The CGIC range from 1 to 7, where 1=very much improved since the initiation of treatment; 4=no change from baseline; 7=very much worse since the initiation of treatment.

CGIC

Overall Study

Norman Relkin, MD, PhD

Intravenous Immunoglobulin

Weill Medical College of Cornell University

Phase II Study of Intravenous Immunoglobulin (IVIg) for Alzheimer's Disease

A Placebo-controlled, Randomized, Double-Blind Phase II Clinical Study of Gammagard Intravenous Immunoglobulin (IVIg) for Treatment of Mild to Moderate Alzheimer's Disease

communication disorders/uždegimas

Impact of Photobiomodulation (PBM) on Biomarkers of Alzheimer's Disease

The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children

Low Dose RT to Reduce Cerebral Amyloidosis in Early Alzheimer's

Phase II Study of Intravenous Immunoglobulin (IVIg) for Alzheimer's Disease

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