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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCI Patients | Adult participants who are seeking neurological assessments for Mild Cognitive Impairment (MCI) at a participating clinic/study site. |
| |
| Healthy Controls | Healthy participants without a prior MCI or memory impairment diagnosis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fNIRS measurement | Other | Kernel Flow2 measurements. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brain hemodynamic activity with TD-fNIRS | This includes changes in the concentration of oxygenated and deoxygenated hemoglobin as measured by the change in light absorption. | About 1 hour during the study visit |
| Optical properties of the brain with TD-fNIRS | This measures how much light is absorbed at different points on the head. | About 1 hour during the study visit |
| Physiological features with TD-fNIRS | This includes cardiac measures, such as heart rate (HR) and heart rate variability (HRV). | About 1 hour during the study visit |
| Measure | Description | Time Frame |
|---|---|---|
| Mini-Mental State Evaluation (MMSE) | Clinician-administered screening tool used to systematically and thoroughly assess mental status through five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. Patient cohort only. Scores range between 0-30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment. |
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Inclusion Criteria:
Patients
Healthy Controls
Exclusion Criteria:
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:
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:
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Adult participants seeking neurological assessments for Mild Cognitive Impairment (MCI) at a participating clinic/study site. A separate cohort of age-matched healthy participants will be recruited as the control group. The current study, including the acquired data and participation in the study, has no influence on diagnosis or treatment decisions.
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Perdue, PhD | Kernel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Research Center of Southern California | Carlsbad | California | 92011 | United States | ||
| BrainHealth Solutions |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Within 6 months of the study visit |
| Mini-Cog | A fast and simple screening test to help detect cognitive impairment in its early stages that will be used to confirm normal cognitive function in the control group. Healthy control cohort only. Scores range between 0-5. Participants who score 0-2 are considered to indicate higher likelihood of cognitive impairment. | About 30 minutes during the study visit |
| Geriatric Depression Scale (Short Form) | 15-item self report measure of depression in older adults. Scores range between 0-15. Higher scores indicate high severity of depression. | About 30 minutes during the study visit |
| General Anxiety Disorder | Seven-item self report measure used to assess participant anxiety. Scores range between 0-21. Higher scores indicate high severity of anxiety. | About 30 minutes during the study visit |
| Apathy Evaluation Scale | 18-item self-rated measure used to assess and quantify emotional, behavioral, and cognitive aspects of apathy. Scores range between 18-72. Higher scores indicate high severity of apathy. | About 30 minutes during the study visit |
| Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS ADL-MCI) | 15-item self report measure used to assess performance of activities of daily life. Scores range between 0-45. Higher scores indicate declining cognition. | About 30 minutes during the study visit |
| Costa Mesa |
| California |
| 92626 |
| United States |
| The Research Center of Southern California | Escondido | California | 92029 | United States |
| Kernel | Los Angeles | California | 90232 | United States |
| Syrentis Clinical Research | Santa Ana | California | 92705 | United States |
| The Research Center of Southern California | Temecula | California | 92592 | United States |