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Completed

NCT Number: NCT05996575

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Research Center of Southern California, Carlsbad, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

fNIRS measurement

Other

Kernel Flow2 measurements.

Primary outcomes

  1. Brain hemodynamic activity with TD-fNIRS

    Time frame: About 1 hour during the study visit

    This includes changes in the concentration of oxygenated and deoxygenated hemoglobin as measured by the change in light absorption.

  2. Optical properties of the brain with TD-fNIRS

    Time frame: About 1 hour during the study visit

    This measures how much light is absorbed at different points on the head.

  3. Physiological features with TD-fNIRS

    Time frame: About 1 hour during the study visit

    This includes cardiac measures, such as heart rate (HR) and heart rate variability (HRV).

Secondary outcomes

  1. Mini-Mental State Evaluation (MMSE)

    Time frame: Within 6 months of the study visit

    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.

  2. Mini-Cog

    Time frame: About 30 minutes during the study visit

    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.

  3. Geriatric Depression Scale (Short Form)

    Time frame: About 30 minutes during the study visit

    15-item self report measure of depression in older adults. Scores range between 0-15. Higher scores indicate high severity of depression.

  4. General Anxiety Disorder

    Time frame: About 30 minutes during the study visit

    Seven-item self report measure used to assess participant anxiety. Scores range between 0-21. Higher scores indicate high severity of anxiety.

  5. Apathy Evaluation Scale

    Time frame: About 30 minutes during the study visit

    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.

  6. Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS ADL-MCI)

    Time frame: About 30 minutes during the study visit

    15-item self report measure used to assess performance of activities of daily life. Scores range between 0-45. Higher scores indicate declining cognition.

Sponsors and collaborators

Lead sponsor

Kernel

Industry

Registry information

Official study title

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

Acronym: IMPACT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2023
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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