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Light beams to the brain: a new hope for Alzheimer's?
NCT ID NCT04784416
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new, non-invasive treatment called transcranial photobiomodulation (t-PBM) for people with mild cognitive impairment or early Alzheimer's disease. 196 participants aged 65-85 will receive either real or fake light therapy to the forehead for 8 weeks. The goal is to see if this light treatment can improve memory and thinking skills.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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196 people
The number who actually took part.
- Started
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Apr 2021
- Expected to finish
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Jan 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Able to give written informed consent and follow study procedures. 2. Age \> or = 65 years and \< or = 85 years. 3. Meets the Petersen MCI criteria for Amnestic MCI (single and multiple domain) with a Clinical Dementia Rating (CDR) between 0.5-1.0, and a Functional Assessment Staging (FAST) of 1-4. 4. Be willing to identify an informed relative, family member, spouse, or friend for study staff to interview to confirm subject reports as per UDS 3.0 guidelines; however the lack of a study informant is not exclusionary. 5. Have at least a high school diploma/12 years of education. 6. Participants with current mild MDD may be allowed to participate, given that mild MDD does not affect cognition and does not pose increased risk to the participant, as determined by site PI on a case-by-case basis. Exclusion Criteria: 1. Unwilling/unable to comply with study procedures. 2. Other diagnosis of dementia (i.e. not Alzheimer's type), history of brain tumor, MRI evidence of brain damage or brain disease including significant trauma, hydrocephalus, seizures, intellectual disability, or other serious neurological disorder (e.g. Parkinson's disease or other movement disorders). 3. History of significant cerebrovascular pathology (e.g., significant stroke). Subjects with a history of cardiovascular disease (e.g., myocardial infarction) will be allowed to participate at site PI's discretion, on a case-by-case basis, given that the cardiovascular disease is stable and does not reflect the presence of significant cerebrovascular pathology. 4. Clinically unstable systemic medical disorders. 5. Current DSM-5 diagnosis of alcohol or drug use disorder or other major psychiatric illness (e.g., schizophrenia, bipolar, PTSD, depression). Participants with current mild MDD may be allowed to participate, given that mild MDD does not affect cognition and does not pose increased risk to the participant, as determined by site PI on a case-by-case basis. Participants with current moderate/severe MDD will be excluded. 6. Clinical or laboratory evidence of hypothyroidism. 7. Clinically significant abnormal findings of laboratory parameters or at physical examination. 8. Medications affecting cognition (e.g., narcotic analgesics; chronic use of medications with anticholinergic activity, anti-Parkinsonian medications, antipsychotic meds, etc.). Stable use (i.e., = 6 months) of memantine or acetylcholinesterase inhibitors will be allowed. 9. Family history of early onset (\<60 y/o) dementia. 10. Past intolerance or hypersensitivity to t-PBM. 11. Significant skin conditions on the subject's scalp in the area of the procedure sites. 12. Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment. 13. Any type of implants in the head, whose functioning might be affected by t-PBM. 14. The completion of study imaging procedures is highly encouraged, but not mandatory for participants with extenuating circumstances (e.g., having prosthetic devices or metallic foreign bodies that constitute hazards for MRI, unable to get PET due to previous level of radiation exposure, having claustrophobia, having a large body size and shape).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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NYU Langone Health
New York, New York, 10016, United States
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Nathan Kline Institute
Orangeburg, New York, 10962, United States
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