Clinical trial NCT05996575: Investigating Mild Cognitive Impairment in Patients And Controls With TD-fNIRS
Official title: IMPACT: Investigating Mild Cognitive Impairment in Patients And Controls With TD-fNIRS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Keywords: functional Near Infrared Spectroscopy (fNIRS)
Aging
Lead sponsor: Kernel
Sponsor class: INDUSTRY
First posted: 2023-08-18
Enrollment: 133
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Brain hemodynamic activity with TD-fNIRS
timeFrame: About 1 hour during the study visit
measure: Optical properties of the brain with TD-fNIRS
timeFrame: About 1 hour during the study visit
measure: Physiological features with TD-fNIRS
timeFrame: About 1 hour during the study visit
Secondary outcomes:
measure: Mini-Mental State Evaluation (MMSE)
timeFrame: Within 6 months of the study visit
measure: Mini-Cog
timeFrame: About 30 minutes during the study visit
measure: Geriatric Depression Scale (Short Form)
timeFrame: About 30 minutes during the study visit
measure: General Anxiety Disorder
timeFrame: About 30 minutes during the study visit
measure: Apathy Evaluation Scale
timeFrame: About 30 minutes during the study visit
measure: Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS ADL-MCI)
timeFrame: About 30 minutes during the study visit
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: The Research Center of Southern California
state: California
city: Costa Mesa
country: United States
facility: BrainHealth Solutions
state: California
city: Escondido
country: United States
facility: The Research Center of Southern California
state: California
city: Los Angeles
country: United States
facility: Kernel
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Temecula
country: United States
facility: The Research Center of Southern California
state: California
Study officials:
affiliation: Kernel
name: Katherine Perdue, PhD
role: PRINCIPAL_INVESTIGATOR
References: