Investigating Mild Cognitive Impairment in Patients And Controls With TD-fNIRS
Completed
Conditions studied: Mild Cognitive Impairment
In brief
The goal of the proposed observational, multi-site study is to use fNIRS neurophysiological data recorded during a battery of tasks to detect MCI within a cohort consisting of patients and age-matched healthy controls. Furthermore, the investigators aim to explore whether they can measure the severity of MCI symptoms in the patient population. If successful, this approach enables clinicians to track the disease at its source-the brain; possibly allowing for earlier detection of MCI and its progression, and ultimately more efficient interventions.
Key facts
- Study ID
- NCT05996575
- Run by
- Kernel
- People needed
- 133
- Starts
- 2023-07-25
- Expected to finish
- 2024-06-13
- Last updated by the study team
- 2024-07-03
Who can join
Age: 55 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients
- Must have a diagnosis of MCI (amnesiac or non-amnesiac) as determined by clinician
- Adults (older adults) between the ages of 55-85 years inclusive at time of enrollment
- Ability to perform informed consent on their own
- Fluent in English (speaking and reading)
- Healthy Controls
- Adults (older adults) between the ages of 55-85 years inclusive at time of enrollment
- Ability to perform informed consent on their own
- Fluent in English (speaking and reading)
You may not qualify if…
- Patients
- Alzheimer's or dementia diagnosis
- Current substance or alcohol dependence, and/or alcohol or substance abuse as determined by CAGE-AID assessment for drug and alcohol abuse. A score of 2 or higher would result in exclusion.
- Has uncorrected major visual or auditory deficits that would prevent them from completing a study task
- Current or recent (in the past 6 months) chemotherapy and/or radiation for any cancer
- Major medical illnesses and psychiatric conditions (other than MCI) including:
- Severe/uncontrolled Diabetes, hypertension and hypothyroidism that could pose secondary causes of cognitive decline
- Parkinson's disease
- Motor neuron diseases
- Multiple Sclerosis
- Brain Tumor
- Stroke
- Encephalitis
- Meningitis
- Epilepsy
- TBI with serious results (coma, unconscious for >2 hrs, or skull fracture)
- Current serious psychiatric conditions (bipolar disorder, schizophrenia, or psychosis)
- Healthy Controls
- Prior MCI or memory impairment diagnosis
- First-degree relative with dementia or clinically relevant memory problems
- Alzheimer's or dementia diagnosis
- Current substance or alcohol dependence, and/or alcohol or substance abuse as determined by CAGE-AID assessment for drug and alcohol abuse. A score of 2 or higher would result in exclusion.
- Has uncorrected major visual or auditory deficits that would prevent them from completing a study task
- Current or recent (in the past 6 months) chemotherapy and/or radiation for any cancer
- Major medical illnesses and psychiatric conditions including:
Where it is running
- The Research Center of Southern California — Carlsbad, California, United States
- BrainHealth Solutions — Costa Mesa, California, United States
- The Research Center of Southern California — Escondido, California, United States
- Kernel — Los Angeles, California, United States
- Syrentis Clinical Research — Santa Ana, California, United States
- The Research Center of Southern California — Temecula, California, United States
Full record on ClinicalTrials.gov
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