Status:
COMPLETED
Investigating Mild Cognitive Impairment in Patients And Controls With TD-fNIRS
Lead Sponsor:
Kernel
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
55-85 years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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:
- 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)
Key Trial Info
Start Date :
July 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 13 2024
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT05996575
Start Date
July 25 2023
End Date
June 13 2024
Last Update
July 3 2024
Active Locations (6)
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1
The Research Center of Southern California
Carlsbad, California, United States, 92011
2
BrainHealth Solutions
Costa Mesa, California, United States, 92626
3
The Research Center of Southern California
Escondido, California, United States, 92029
4
Kernel
Los Angeles, California, United States, 90232