Phase
Condition
Mild Cognitive Impairment
Treatment
Active NIR-PBM
Sham NIR-PBM
Clinical Study ID
Ages 65-89 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 65-89 years, at least 8th grade education, community dwelling
Subjective report of cognitive complaints with scores >16 on the Cognitive ChangeIndex (CCI-20)
No evidence of dementia or mild cognitive impairment based on cognitive screening (i.e., Montreal Cognitive Assessment (MoCA) score within normal limits for age,education and sex using the National Alzheimer's Coordinating Center (NACC) UniformData Set (UDS) norms.
No psychometric evidence of cognitive impairment based on performance on theNeuropsychological Battery from the NACC Unified Data Set, version 3. Scores onthese measures cannot be lower than 5th percentile below normative values based onage, education, and gender.
Reading at > 8th grade level based on the reading subtest of the Wide RangeAchievement Test- IV.
Global Clinic Dementia Rating (CDR) score must be 0
Family history of dementia/probable Alzheimer's disease in first degree relative (parents, children, siblings)
Willingness to be randomized to Sham or Active Intervention
Can devote 12 weeks to the intervention with additional time for pre and posttesting
Normal functional behavior in terms of daily activities, based on the FunctionalActivities Scale
Able to perform cognitive and emotion measures on a computer
In line with recommendations of the Subjective Cognitive Decline (SCD) task force aninformant must be available for two reasons: a) to provide information about theparticipant's complaints using the informant version of the CCI-20, and b) tocorroborate normal IADL's on the Functional Activity Questionnaire.
Exclusion
Exclusion Criteria:
Sensory loss (vision, hearing) or motor deficits that would preclude participationin the experimental tasks or neuropsychological assessment
English as a second language
Inability to undergo brain imaging due to claustrophobia or implants such aspacemakers, heart valves, brain aneurysm clips, orthodontics, non-removable bodyjewelry, or shrapnel containing ferromagnetic metal
Previous major strokes or other known significant brain abnormalities or diseasesaffecting the brain and/or cognition (e.g.,Parkinson disease, multiple sclerosis,seizure disorder, brain surgery, moderate traumatic brain injury (TB)I, Rapid EyeMovement (REM) Behavior Sleep Disorder, untreated sleep apnea, etc.)
Unstable and uncontrolled medical conditions (metastatic cancer, HIV,moderate-severe kidney disease, uncontrolled diabetes, uncontrolled hypertension,severe cardiac disease, etc.). No current cancer diagnosis.
Current or past history of major psychiatric disturbance including schizophrenia, oractive psychosis, bipolar disorder, current major depressive episode, currentalcohol or substance abuse or history thereof within the past six months.
Use of antipsychotics, sedatives, or other medications with significantanticholinergic properties (due to potential influence on memory)
Use of prescribed 'memory enhancing' medications such as Aricept or Namenda
Use of photo-sensitive medications such as steroids or retin-A within 15 days of thestudy intervention.
Previous participation in a cognitive training study within the last 6 months orcurrent involvement in another study involving cognitive, physical or otherintervention at the time of participation
Study Design
Study Description
Connect with a study center
University of Arizona
Tucson, Arizona 85721
United StatesSite Not Available
University of Arizona
Tucson 5318313, Arizona 5551752 85721
United StatesSite Not Available
University of Florida McKnight Brain Institute
Gainesville, Florida 32610
United StatesSite Not Available
University of Florida McKnight Brain Institute
Gainesville 4156404, Florida 4155751 32610
United StatesSite Not Available

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