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

HI, LLC (Kernel)

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Other: fNIRS measurement

Study type: Observational

Funder types: Industry

Identifiers

NCT05996575

KER2023-3-IMPACT

Details and patient eligibility

About

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.

Enrollment: 133 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

133 participants in 2 patient groups

MCI Patients

Description:

Adult participants who are seeking neurological assessments for Mild Cognitive Impairment (MCI) at a participating clinic/study site.

Treatment:

Other: fNIRS measurement

Healthy Controls

Description:

Healthy participants without a prior MCI or memory impairment diagnosis.

Treatment:

Other: fNIRS measurement