Testing a new light therapy for older adults at risk for Alzheimer's disease

Revitalizing Cognition in Older Adults at Risk for Alzheimer's Disease With Near-Infrared Photobiomodulation

This study is testing a new light therapy to see if it can improve brain health and thinking skills in older adults who are at risk for Alzheimer's disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 65 Years to 89 Years
• Sex: All
• Sponsor: University of Florida (Academic / other)
• Locations: 2 sites (Tucson, Arizona and 1 other locations)
• Trial ID: NCT04018092 on ClinicalTrials.gov

What this trial studies

This multi-site, double-blinded, randomized sham-controlled Phase II clinical trial aims to evaluate a novel therapeutic intervention using near-infrared light (NIR) to enhance brain health in older adults at risk for Alzheimer's disease. The study will involve 168 participants aged 65-89 who report cognitive complaints and have a family history of Alzheimer's. Participants will be randomized to receive either active NIR treatment or a sham treatment over a 12-week period, with assessments of cognitive performance and brain health conducted through advanced imaging techniques. The goal is to determine if NIR stimulation can positively influence mitochondrial function and cognitive outcomes.

Who should consider this trial

Good fit: Ideal candidates are cognitively normal older adults aged 65-89 with subjective cognitive complaints and a first-degree family history of Alzheimer's disease.

Not a fit: Patients with diagnosed dementia or mild cognitive impairment, or those without a family history of Alzheimer's disease, may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could provide a low-risk and cost-effective method to improve cognitive health and potentially delay the onset of Alzheimer's disease in at-risk older adults.

How similar studies have performed: While this approach is novel, preliminary pilot studies have shown positive effects of NIR stimulation on cognitive health, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

* Age 65-89 years, at least 8th grade education, community dwelling
* Subjective report of cognitive complaints with scores \>16 on the Cognitive Change Index (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 NACC Uniform Data Set (UDS) norms.
* No psychometric evidence of cognitive impairment based on performance on the Neuropsychological Battery from the NACC Unified Data Set, version 3. Scores on these measures cannot be lower than 1.0 SD (16th %ile) below normative values based on age, education, and gender.
* Reading at \> 8th grade level based on the reading subtest of the Wide Range Achievement 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 post testing
* Normal functional behavior in terms of daily activities, based on the Functional Activities Scale
* Able to perform cognitive and emotion measures on a computer
* In line with recommendations of SCD task force an informant must be available for two reasons: a) to provide information about the participant's complaints using the informant version of the CCI-20, and b) to corroborate normal IADL's on the Functional Activity Questionnaire.

Exclusion Criteria:

* Sensory loss (vision, hearing) or motor deficits that would preclude participation in the experimental tasks or neuropsychological assessment
* English as a second language
* Inability to undergo brain imaging due to claustrophobia or implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics, non-removable body jewelry, or shrapnel containing ferromagnetic metal
* Previous major strokes or other known significant brain abnormalities or diseases affecting the brain and/or cognition (e.g.,Parkinson disease, multiple sclerosis, seizure disorder, brain surgery, moderate TBI, 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, or active psychosis, bipolar disorder, current major depressive episode, current alcohol or substance abuse or history thereof within the past six months.
* Use of antipsychotics, sedatives, or other medications with significant anticholinergic 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 the study intervention.
* Previous participation in a cognitive training study within the last 6 months or current involvement in another study involving cognitive, physical or other intervention at the time of participation

Where this trial is running

Tucson, Arizona and 1 other locations

• University of Arizona — Tucson, Arizona, United States (Not_yet_recruiting)
• University of Florida McKnight Brain Institute — Gainesville, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Dawn Bowers, Ph.D — University of Florida
• Study coordinator: Dawn Bowers, Ph.D.

Conditions Cognitive Aging; Alzheimer Disease, Protection Against