Start: April 27, 2021
End: November 30, 2025
What Is This Study About?
This study, named TRAP-AD, will examine whether light-based brain stimulation can improve memory in older adults with amnestic mild cognitive impairment (aMCI). Participants will be randomly assigned to receive light stimulation or a sham for 10 minutes a day, three days a week, for two months. At the start and end of the study and one month after study completion, participants will undergo PET and MRI brain scans as well as a series of cognitive and neuropsychological tests. Researchers will also collect information on any adverse side effects of the treatment.
Do I Qualify To Participate in This Study?
- Diagnosis of aMCI with:
- Clinical Dementia Rating score between 0.5 and 1
- Functional Assessment Staging score between 1 and 3
- Family member who is available to confirm participant information and responses
- High school diploma or 12 years of education
Must NOT have:
- Diagnosis of dementia, other than aMCI, or other significant neurological disorder (Parkinson's disease, other movement disorders)
- Any serious, chronic medical illness or condition that could interfere with the study, including:
- History of a brain tumor, brain damage, or brain disease, including significant trauma, hydrocephalus, seizures, intellectual disability
- History of significant cardiovascular or cerebrovascular disease (e.g., myocardial infarction, stroke)
- Major psychiatric illness (e.g., schizophrenia, bipolar, PTSD, depression)
- Current alcohol or drug abuse
- Any abnormal laboratory test results
- Currently taking any medications or supplements that affect cognition (e.g., narcotic analgesics, chronic use of medications with anticholinergic activity, anti-Parkinsonian medications, antipsychotic medications)
- If taking memantine or acetylcholinesterase inhibitors, dosage must be stable for at least six months before starting study
- Family history of early onset dementia, with symptoms appearing before 60 years of age
- Use of any light-activated drugs within two weeks of starting the study
- Any condition that may make having an MRI or PET brain scan unsafe (e.g., metal shrapnel, heart pacemaker, severe claustrophobia, epilepsy, body size and shape that prevents a comfortable fit in scanners)
- Any conditions that may make study intervention unsafe, including:
- Past intolerance or hypersensitivity to light stimulation
- Significant skin conditions on the scalp
- Device implants in the head, whose functioning might be affected by light stimulation
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Dan Iosifescu, MD
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: NYU Langone Health
National Institutes of Health (NIH)
Source: ClinicalTrials.gov ID: NCT04784416