Mild Cognitive ImpairmentIMPACTNCT05996575
Investigating Mild Cognitive Impairment in Patients And Controls With TD-fNIRS
An observational study of Mild Cognitive Impairment, run by Kernel at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- fNIRS measurement
- How many people
- 133 participants
- Where
- 6 sitesUnited States
- Study dates
- 25 Jul 2023to 13 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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:
Show all 36Show fewer
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
The Research Center of Southern California
Carlsbad, California, 92011
BrainHealth Solutions
Costa Mesa, California, 92626
The Research Center of Southern California
Escondido, California, 92029
Kernel
Los Angeles, California, 90232
Syrentis Clinical Research
Santa Ana, California, 92705
The Research Center of Southern California
Temecula, California, 92592
About this study
Official title: 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- fNIRS measurement
- Keywords
- functional Near Infrared Spectroscopy (fNIRS), Aging
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fNIRS measurementOther
Kernel Flow2 measurements.
| Study group | Role | What they receive |
|---|---|---|
| MCI Patients | Adult participants who are seeking neurological assessments for Mild Cognitive Impairment (MCI) at a participating clinic/study site. Receives: Other: fNIRS measurement | |
| Healthy Controls | Healthy participants without a prior MCI or memory impairment diagnosis. Receives: Other: fNIRS measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: About 1 hour during the study visit
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: About 30 minutes during the study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start25 Jul 2023
- Primary completion13 Jun 2024
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kernel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katherine Perdue, PhD, Principal investigator, Kernel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996575
- Sponsor's protocol ID
- KER2023-3-IMPACT
- Acronym
- IMPACT
- Status last verified
- Jul 2024
- First submitted
- 2 Aug 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT: Investigating Mild Cognitive Impairment in Patients And Controls With TD-fNIRS
- ClinicalTrials.gov ID
- NCT05996575
- Acronym / sponsor ID
- IMPACT / KER2023-3-IMPACT
- Conditions
- Mild Cognitive Impairment
- Keywords
- functional Near Infrared Spectroscopy (fNIRS), Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- KernelIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCI Patients | – | Other: fNIRS measurementAdult participants who are seeking neurological assessments for Mild Cognitive Impairment (MCI) at a participating clinic/study site. |
| Healthy Controls | – | Other: fNIRS measurementHealthy participants without a prior MCI or memory impairment diagnosis. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (36 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fNIRS measurementKernel Flow2 measurements. | Other | Healthy Controls, MCI Patients |
Primary outcome
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.
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.
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).
6 secondary outcomes
Mini-Mental State Evaluation (MMSE)
Time frame: Within 6 months of the study visit
Mini-Cog
Time frame: About 30 minutes during the study visit
Geriatric Depression Scale (Short Form)
Time frame: About 30 minutes during the study visit
General Anxiety Disorder
Time frame: About 30 minutes during the study visit
Apathy Evaluation Scale
Time frame: About 30 minutes during the study visit
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Perdue, PhD principal investigator
Kernel
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by Kernel at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain hemodynamic activity with TD-fNIRS (time frame: About 1 hour during the study visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.