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Behavioural Intervention
Transcranial Photobiomodulation for Alzheimer's Disease
Phase 2
Recruiting
Led By Dan Iosifescu, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 65 years and ≤ 85 years.
Meets the Petersen MCI criteria for Amnestic MCI (single and multiple domain) with a Clinical Dementia Rating (CDR) between 0.5 to 1, and a Functional Assessment Staging (FAST) of 1-3.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3
Awards & highlights
Study Summary
This trial will study the effects of t-PBM, a pulsed, 808nm wavelength laser delivery to the forehead, on amnestic Mild Cognitive Impairment.
Who is the study for?
This trial is for people aged 65-85 with mild cognitive impairment or early Alzheimer's, who have at least a high school education and can consent to the study. Participants need a relative to confirm reports and must fit comfortably in imaging scanners without claustrophobia or metal implants that interfere with MRI.Check my eligibility
What is being tested?
The TRAP-AD study tests if tPBM (a type of light therapy) helps brain function in those with memory issues due to aging. It involves daily sessions over 8 weeks, comparing active tPBM against a sham treatment while monitoring changes through advanced brain scans like PET and fMRI.See study design
What are the potential side effects?
Potential side effects are not detailed here but could include discomfort from wearing the device, skin irritation at application sites, or reactions related to light sensitivity for those undergoing active tPBM treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 65 and 85 years old.
Select...
I have mild memory loss that affects my daily life, but I am not severely impaired.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Addenbrooke's Cognitive Examination (ACE-III) Score
Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS) Total Scale Index Score.
Change in Systemic Assessment for Treatment Emergent Events - Specific Inquiry (SAFTEE-SI) Score
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transcranial Photobiomodulation (t-PBM)Experimental Treatment2 Interventions
Group II: ShamPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-MK-6240
2019
Completed Phase 2
~220
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,636 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,454 Total Patients Enrolled
Alzheimer's AssociationOTHER
89 Previous Clinical Trials
40,638 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- A family member had dementia before turning 60.I have mild memory loss that affects my daily life, but I am not severely impaired.I have no significant abnormal lab results or physical exam findings.You are afraid of small spaces or have metal objects in your body that would prevent you from having an MRI scan.I have not used any light-activated drugs in the last 14 days.I do not have a history of serious brain conditions or other types of dementia besides Alzheimer's.I do not have any unstable health conditions.I have serious skin issues on my scalp where a procedure is planned.You have a current diagnosis of alcohol or drug addiction or a major mental illness such as schizophrenia, bipolar disorder, PTSD, or depression.I am not on any medication that affects my thinking, except for stable use of memantine or acetylcholinesterase inhibitors for over 6 months.I have had a heart attack or stroke.I am between 65 and 85 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Sham
- Group 2: Transcranial Photobiomodulation (t-PBM)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT04784416 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who can sign up to be part of this research project?
"This study is looking for 125 participants with Alzheimer disease aged 65 and 85. Candidates are required to meet the following criteria: Age ≥ 65 years and ≤ 85 years, Meets the Petersen MCI criteria for Amnestic MCI (single and multiple domain) with a Clinical Dementia Rating (CDR) between 0.5 to 1, and a Functional Assessment Staging (FAST) of 1-3, Consents to permit and identifies a willing informed relative, family member, or spouse for study staff to interview to confirm subject reports as per UDS 3.0 guidelines., Have at least a high school"
Answered by AI
How many people are signing up for this clinical trial?
"That is accurate. The clinical trial was originally posted on 4/27/2021, and as of right now, they are still recruiting participants. They are looking for a total of 125 people at 3 different sites."
Answered by AI
How can interested individuals sign up for this research project?
"The study, which was originally advertised on clinicaltrials.gov on April 27th 2021, is still recruiting patients."
Answered by AI
Could you explain the age requirements for this clinical trial?
"The age requirements to participate in this trial are being 65 years or older, and younger than 85 years old."
Answered by AI
Has 18F-MK-6240 received the go-ahead from the FDA?
"There is some evidence that 18F-MK-6240 is safe, but none to support its efficacy. Our team rates it as a 2."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
Massachusetts
New York
What site did they apply to?
Massachusetts General Hospital
NYU Langone Health
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
Starting to see signs if memory loss. Exercise daily plus on escitalopram and donepezil. Motivated to improve.
PatientReceived no prior treatments
Exercise daily plus on escitalopram and donepezil. Motivated to improve. And recover!
PatientReceived 2+ prior treatments
I currently take Memantine (2x/day) and Donezapril (PM) and am functioning well. I still deal with tiredness and some memory issues, though not consistently).
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long do screening visits take? How many in person visits? How long is the study?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- NYU Langone Health: < 24 hours
Average response time
- < 2 Days
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