An Omnilux device will be used to put NIR light on the head and forehead of the subject age 18-25 or 65-85. The device is a low risk device as determined by the IRB. Thirty (30) subjects will receive this light at 6 visits over 16 weeks.
An automated interactive software self-test will be used at baseline and at three subsequent visits to quantify subject cognitive functions.

An Omnilux Device will be used at a safe wavelength not associated with photobiomodulation, putting sham light on the head and forehead of the subject age 18-25 or 65-85. The device is a low risk device as determined by the IRB. Thirty (30) subjects will receive this light at 6 visits over 16 weeks.
An automated interactive software self-test will be used at baseline and at three subsequent visits to quantify subject cognitive functions.

Disease Type and/or Category Not Applicable

The Omnilux LED array sources can be changed to emit different wavelength.

Omnilux

Massachusetts General Hospital

Effectiveness of Light for Enhancement of Cognition by Transcranial Repeated Application (ELECTRA)

Effectiveness of Light for Enhancement of Cognition by Transcranial Repeated Application (ELECTRA): a Placebo-Controlled Study of Efficacy, Tolerability and Acceptability in Healthy Adult Volunteers

The median latency from stimulus onset to the subject's response button touch (i.e. emotion chosen) for all problems during assessment blocks.

The number of times the subject chose the incorrect box for a stimulus on assessment problems, plus an adjustment for the estimated number of errors they would have made on any problems, attempts and recalls they did not reach

The mean duration between the onset of the stimulus and the release of the button. Calculated for correct, assessed trials where the stimulus could appear in any one of five locations.

A' (A prime) is the signal detection measure of sensitivity to the target, regardless of response tendency (the expected range is 0.00 to 1.00; bad to good). In essence, this metric is a measure of how good the subject is at detecting target sequences.

The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials.

Between errors are defined as times the subject revisits a box in which a token has previously been found. This is calculated for trials of four, six and eight tokens.

Data will only be shared within the study staff member on the approved Institutional Review Board MGH protocol and to the sponsor, the AFOSR

Richard Rox Anderson, MD

Director, Wellman Center for Photomedicine

Placebo capsule given three times daily X 3 weeks

Resveratrol 1 gram three times daily X 3 weeks

Metabolic Syndrome

Resveratrol

Placebo

Vanderbilt University

Baylor University

Resveratrol in Metabolic Syndrome: Effect on Platelet Hyper-reactivity and HDL Lipid Peroxidation

Measure platelet-monocyte aggregates by flow cytometry

Measure malondialdehyde adducts of platelet proteins

Measure superoxide production by platelets

Measure thromboxane to assess inflammation

Measure change in malondialdehyde adducts in HDL proteins

John Oates

Professor of Medicine

tauroursodeoxycholic acid di-hydrate
tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year

TUDCA

excipient lactose
Placebo: identical placebo by oral route at the same dosing schedule

Total

Sex: Female, Male

Region of Enrollment

Responder patients were defined as those subjects showing an improvement of at least 15% in the ALSFRS-R slope during the treatment period as compared to the lead-in period.

excipient lactose
Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose

The Proportion of Responder Patients in the Two Treatment Groups According the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)-R Slope.

Forced Vital Capacity (FVC) %

SF-36 Quality of Life Rating Scale

Time to Tracheostomy From Starting of Study Medication Dosing (if Appropriate)

Survival Time From Starting of Study Medication Dosing (if Appropriate)

ALSFRS-R at Study End

laboratory tests, patients' reports and the investigator's judgments

Incidence and Severity of Adverse Events, and Their Relationship to Treatment

Medical Research Council Scores for Right and Left Muscle Groups

Overall Study

Alberto Albanese

Amyotrophic Lateral Sclerosis

Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year

tauroursodeoxycholic acid (TUDCA)

identical placebo by oral route at the same dosing schedule

Fondazione IRCCS Istituto neurologico Carlo Besta

Efficacy and Tolerability of Tauroursodeoxycholic Acid in Amyotrophic Lateral Sclerosis

A Randomized, Double-blind Multicenter Pilot Study vs. Placebo for the Evaluation of Efficacy and Tolerability of Tauroursodeoxycholic Acid Administered by Oral Route as Add on Treatment in Patients Affected by Amyotrophic Lateral Sclerosis

cytochrome c/moždani udar

Effectiveness of Light for Enhancement of Cognition by Transcranial Repeated Application (ELECTRA)

Resveratrol in Metabolic Syndrome: Effect on Platelet Hyper-reactivity and HDL Lipid Peroxidation

Efficacy and Tolerability of Tauroursodeoxycholic Acid in Amyotrophic Lateral Sclerosis

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