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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.
Must not have
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).
History of significant cardiovascular or cerebrovascular pathology (e.g., myocardial infarction; stroke).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3
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.
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.
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.
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I have mild memory loss that affects my daily life, but I am not severely impaired.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a history of serious brain conditions or other types of dementia besides Alzheimer's.
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I have had a heart attack or stroke.
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I do not have any unstable health conditions.
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A family member had dementia before turning 60.
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I have serious skin issues on my scalp where a procedure is planned.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
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
1,408 Previous Clinical Trials
855,618 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,811 Previous Clinical Trials
8,161,133 Total Patients Enrolled
Alzheimer's AssociationOTHER
97 Previous Clinical Trials
42,514 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
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