Revitalize Cognition: Near Infrared Stimulation in Older Adults

There is a dearth of clinically meaningful treatment options at this point in time for
individuals who are at increased risk for transitioning to dementia, particularly those with
the amnestic variant of mild cognitive impairment (aMCI). While waiting for causative cures
and preventive approaches, investigators are faced with the task of identifying modifying
therapies that might alter the course or slow down the transition from normal cognition to
MCI to dementia.

The proposed study hopes to contribute to this mission by testing the viability of a
different type of intervention, one involving transcranial delivery of near-infrared (NIR)
wavelengths (808-904nm). Near-infrared stimulation is safe, non-invasive and appears to
improve mitochondrial function by promoting increased production of intracellular adenosine
triphosphate (ATP) and possibly improved blood flow. Perhaps most compelling are recent
findings of reduced beta-amyloid and neurofibrillary tangles in transgenic Alzheimer's mouse
models after exposure to real vs sham transcranial NIR stimulation. Preliminary human
involving traumatic brain injury (TBI), stroke, and young adult populations have also been
promising in terms of positive effects of NIR on cognition.

The overall goal of the present study is to learn whether this unconventional NIR stimulation
approach has potential for improving cognition in older adults. To do so, investigators will
conduct a randomized sham controlled pilot trial. The intervention will involve six sessions,
over a 2-week period in which real or sham stimulation is transcranially applied using a
delivery system that has been FDA-approved as a nonsignificant risk since 2003. Researchers
hope to learn whether NIR stimulation, relative to sham, has positive effects on cognition
and mood in older adults.

Inclusion Criteria:

- Age 62 years or above

- Able to provide informed consent and perform cognitive and mood measures on a computer

- Willingness to be randomized to Sham or Real intervention

- Can devote 2 weeks to the intervention, and additional time for pre and post testing

- 8th grade education and ability to read on 8th grade level based on scores on the
Wechsler Test of Adult Reading (WTAR) or the Wide Range Achievement Test-IV (WRAT-IV);
or a reading test at 14 pt. text

- On stable doses of major medications; Since some older adults with memory complaints
may be prescribed acetylcholinererase inhibitors or related medications by their
primary care physicians (i.e., donepezil, rivastigmine, galantaominhe, memantime, or
other potential memory-enhancing agent(s), we will not exclude them as long as they
have been on stable medications for at least two months and plan to continue this
medication during study participation.

- Willingness to allow a study partner (spouse, family member, friend) to answer
questions about their cognitive, mood, and other behaviors

Exclusion criteria

- Sensory loss (vision, hearing) or motor deficits that would preclude participation in
the experimental cognitive tasks or neuropsychological assessment

- Unstable and uncontrolled medical conditions (metabolic encephalopathy, HIV, moderate
to severe kidney or liver disease)

- Previous major strokes or other known significant brain abnormalities or diseases
affecting cognition (i.e., multiple sclerosis, seizure disorder, brain surgery,
moderate TBI, etc.). No history of brain surgery. Exceptions are a diagnosis of
Parkinson's disease for the PD subgroup.

- Evidence of potential dementia (e.g., scores < 24 on the Mini Mental State Exam
(MMSE), or < 20 on the Montreal Cognitive Assessement (MoCA), or less than 5th
percentile on the Dementia Rating Scale-2 (DRS-2)

- Current or past history of major psychiatric disturbance including schizophrenia, or
active psychosis, bipolar disorder, current major depressive episode, current alcohol
or substance abuse or history thereof within the past six months. This will be
assessed using the Mental Health Screen v.3 (Carroll & McGinley), a modification of
the Structured Clinical Interview for DSM-IV psychiatric disorders. We are not
excluding individuals who are taking antidepressants or anti-anxiety medications,
however, use of antidepressants and anxiolytics will be recorded and data will be
analyzed in post-hoc analyses

- Use of antipsychotics, sedatives, or other medications with significant
anticholinergic properties (due to potential influence on memory)

- Use of photo-sensitive medications such as steroids or retin-A within 15 days of the
study intervention

- Diagnosis of cancer

- Previous participation in a cognitive training study within the last 3 months or
current involvement in another study at VITAL or ReVITALIZE, or another study
involving cognitive training or intervention at the time of participation