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

Mild Cognitive Impairment Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05996575
• Other study ID #: KER2023-3-IMPACT
• Status: Recruiting
• Start date: July 25, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Kernel
• Contact: Katherine Perdue, PhD
• Phone: 323-238-9225
• Email: research[@]kernel.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• fNIRS measurement
Kernel Flow2 measurements.

Locations

Country	Name	City	State
United States	The Research Center of Southern California	Carlsbad	California
United States	BrainHealth Solutions	Costa Mesa	California
United States	The Research Center of Southern California	Escondido	California
United States	Kernel	Los Angeles	California
United States	Syrentis Clinical Research	Santa Ana	California
United States	The Research Center of Southern California	Temecula	California

Sponsors (1)

Lead Sponsor	Collaborator
Kernel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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