Investigating Mild Cognitive Impairment in Patients And Controls With TD-fNIRS (IMPACT)

IMPACT: Investigating Mild Cognitive Impairment in Patients And Controls With TD-fNIRS

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Other: fNIRS measurement

• Study Type: Observational
• Enrollment (Actual): 133

Contacts and Locations

Study Locations

• United States
  • California
    • Carlsbad, California, United States, 92011
      • The Research Center of Southern California
    • Costa Mesa, California, United States, 92626
      • BrainHealth Solutions
    • Escondido, California, United States, 92029
      • The Research Center of Southern California
    • Los Angeles, California, United States, 90232
      • Kernel
    • Santa Ana, California, United States, 92705
      • Syrentis Clinical Research
    • Temecula, California, United States, 92592
      • The Research Center of Southern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

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 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:

  • 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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MCI Patients; Adult participants who are seeking neurological assessments for Mild Cognitive Impairment (MCI) at a participating clinic/study site.	Other: fNIRS measurement; Kernel Flow2 measurements.
Healthy Controls; Healthy participants without a prior MCI or memory impairment diagnosis.	Other: fNIRS measurement; Kernel Flow2 measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Kernel
• Investigators: Principal Investigator: Katherine Perdue, PhD, Kernel

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Actual): June 13, 2024
• Study Completion (Actual): June 13, 2024

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Aging; functional Near Infrared Spectroscopy (fNIRS)
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: KER2023-3-IMPACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No