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New treatment option for Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
Official title Infrared Light for Memory Loss in Mild Cognitive Impairment (MCI)
ClinicalTrials.gov ID: NCT06618807
What this study is testing
- What it's testing
- Mild cognitive impairment (MCI) is a transitional risk state that occurs between the normal aging process and Alzheimer's dementia (AD). On average 32% of patients with MCI will progress to dementia, 62% will stay stable, and about 6% will return to normal cognition at subsequent visits.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Individuals who meet the criteria for MCI of 1) cognitive concern by the subject, informant, or clinician; 2) Montreal Cognitive Assessment (MoCA)...
- Essentially normal functional activities as derived from the CDR. If receiving ongoing cholinesterase inhibitor therapy and/or memantine, must be on...
- MoCA score between 19 and 25 at screening assessment and impairment in learning and memory domain.
You likely can't join if
- Cannot tolerate blood draws. Claustrophobia (fear of small or enclosed spaces), that cannot tolerate MRI scanners\ .
- A pace-maker or other metal implants that would preclude safe use of MRI\ . DSM 5 diagnosis of alcohol or other substance use disorders within the...
- Unstable medical illness, (e.g., uncontrolled diabetes mellitus or hypertension).
- Any history of stroke, seizures, MS, or Lyme disease. Any issues with ambulation, vision, or hearing which could, in the opinion of the investigator...
- Participant does not speak English at a level necessary for the completion of the assessments.
- Has not completed at least a grade eight education, as necessary for the completion of the assessments.
See the full eligibility criteria
- Individuals who meet the criteria for MCI of 1) cognitive concern by the subject, informant, or clinician; 2) Montreal Cognitive Assessment (MoCA) score between 19-25 and impairment in learning and memory domain; 3)...
- Essentially normal functional activities as derived from the CDR. If receiving ongoing cholinesterase inhibitor therapy and/or memantine, must be on a stable dosage for at least the prior 3 months.
- MoCA score between 19 and 25 at screening assessment and impairment in learning and memory domain.
- Cannot tolerate blood draws. Claustrophobia (fear of small or enclosed spaces), that cannot tolerate MRI scanners\ .
- A pace-maker or other metal implants that would preclude safe use of MRI\ . DSM 5 diagnosis of alcohol or other substance use disorders within the past 12 months.
- Unstable medical illness, (e.g., uncontrolled diabetes mellitus or hypertension).
- Any history of stroke, seizures, MS, or Lyme disease. Any issues with ambulation, vision, or hearing which could, in the opinion of the investigator, interfere with their ability to complete assessments.
- Participant does not speak English at a level necessary for the completion of the assessments.
- Has not completed at least a grade eight education, as necessary for the completion of the assessments.
- Currently participating in another clinical research study involving an investigational product.
- History of significant agitation and/or aggression, epileptic seizures. Current neurologic disease affecting cognition other than Alzheimer's disease. Photosensitivity reactions to sunlight or visible light...
- History of recurrent epistaxis within the last 24 weeks or currently taking major anti-coagulants (including warfarin, low molecular weight heparin) Increased skin sensitivity at the treatment site including active...
- Pregnant or lactating or planning to become pregnant. Currently undergoing infrared light therapy treatment. Any reason that, in the opinion of the investigator, might place a participant at unacceptable risk for...
- Note: \ Participants with contraindications for MRI can still enroll in the trial and participate without undergoing the MRI procedure. However, if participants do not have contraindications, undergoing the MRI is...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.