Mild Cognitive Impairment Research Study
Researchers at New York University are investigating an experimental treatment device for cognitive impairment using near-infrared light therapy.
Fast Facts
Struggling with Memory Loss or Memory Impairment
65-85 Years Old
Compensation Provided
Conducted in Orangeburg, NY
Study Background
Researchers at New York University are investigating an experimental treatment device for cognitive impairment using near-infrared light therapy.
The TRAP-AD study is investigating if an experimental treatment device that uses near-infrared light therapy will lead to improved brain function in adults with memory problems.
The treatment, transcranial photobiomodulation (t-PBM), stimulates certain parts of the brain that are thought to be affected in memory impairment. Participants will first complete an assessment of medical history and memory to verify eligibility, undergo medical imaging procedures, and will then be randomized to either t-PBM or sham (placebo) treatment for 8 weeks. Following treatment, cognitive symptoms will be assessed two additional times to detect any improvement.
If you are 65-85 and having problems with your memory, you are invited to apply for this research study, or you may have a caregiver or loved one apply on your behalf. Eventually, the findings of this study might be useful for treating memory issues and improving people’s quality of life.
Study Background
Researchers at New York University are investigating an experimental treatment device for cognitive impairment using near-infrared light therapy.
The TRAP-AD study is investigating if an experimental treatment device that uses near-infrared light therapy will lead to improved brain function in adults with memory problems.
The treatment, transcranial photobiomodulation (t-PBM), stimulates certain parts of the brain that are thought to be affected in memory impairment. Participants will first complete an assessment of medical history and memory to verify eligibility, undergo medical imaging procedures, and will then be randomized to either t-PBM or sham (placebo) treatment for 8 weeks. Following treatment, cognitive symptoms will be assessed two additional times to detect any improvement.
If you are 65-85 and having problems with your memory, you are invited to apply for this research study, or you may have a caregiver or loved one apply on your behalf. Eventually, the findings of this study might be useful for treating memory issues and improving people’s quality of life.
Additional Information
The primary purpose of this research study is to determine if application of near infrared energy to the forehead can help improve thinking and memory in people with mild cognitive impairment (MCI) and early Alzheimer’s Disease (AD).
You may qualify for a study if you meet the following criteria.
Inclusion Criteria:
- 65-85 years old
- Struggled with memory loss or memory impairment
- At least 12 years of education or high school diploma
Exclusion Criteria:
- Unstable medical disorders
- Family history of early onset (before age 60) Alzheimer’s disease
- Other diagnosis of dementia or history of brain tumor
- Intellectual disability or serious neurological disorder, such as Parkinson’s disease
- Significant skin conditions on the forehead
Participation will involve about 31 visits over the course of 5-7 months. The phases of this study are:
- Screening: We will do some tests and procedures to see if you meet the requirements to take part in the study. The study doctor will review the results of these tests and procedures. If you do not meet the requirements, the study doctor will tell you why.
- Baseline: If you do qualify to take part in the study, we will scan your brain to help us understand how it is working at baseline (before the study treatment). We will also give you a single near infrared exposure session (i.e., open label t-PBM session) so that we can understand if and how it changes your brain function immediately (in the short term). This session is NOT part of the treatment you will receive, and you will receive near infrared exposure during this session regardless of your randomization status. We will also do additional tests and procedures to confirm your eligibility for the study.
- Treatments: We will try to schedule the treatments three times a week for 8 weeks.
- Primary Outcome: After completing all treatments, we will ask you to return for another brain scan and neuropsychological testing so we can see if and how all the treatments in combination changed your brain and your memory and thinking.
- Follow-up: We will call you about one week after the primary outcome completion to check on your safety. Then, finally, we will invite you back for more neuropsychological testing 3 months after you finish the treatments to see if they had any lasting effects on your memory or thinking.
Compensation will be provided and all procedures will be covered by the Nathan Kline Institute. If you chose to leave or are withdrawn from the study for any reason before finishing the entire study, you will be paid for each visit completed at the time you leave or are withdrawn.
There is no cost for you to participate in our research study.
