Cognitive Dysfunction
Conditions
Keywords
Mild Cognitive Impairment (MCI), Cognitive Decline, Alzheimer's Disease (AD), Dementia
Brief summary
An observational study to determine outcomes of older adults who are under naturopathic medical care for cognitive complaints at a specific clinic in Southern California.
Detailed description
This prospective observational study will examine patient outcomes associated with individualized, whole-system integrative medical care, provided by a naturopathic physician at a specific clinic in the state of California. Participants will be older adult patients of the clinic who present with objectively measurable cognitive dysfunction, and who elect to voluntarily participate in the study. Participants' cognitive function will be assessed using validated objective (NIH Toolbox) and subjective (NIH Neuro-Quality of Life questionnaires) instruments. The primary outcomes are change from baseline to six months post-baseline in these two instruments. Additionally, physical activity and sleep data will be tracked using wearable telemetry, and neurophysiological parameters will be measured with electroencephalography. Detailed treatment descriptions and adverse events will be tracked.
Interventions
OTHERWhole-practice cognitive optimization
This intervention is a whole-practice intervention that may include nutritional assessment & supplementation, determination of food sensitivities and dietary changes, natural products such as herbal anti-inflammatories, assessment of whole body-burden of toxicants (such as heavy metals and fungal toxins) and steps to reduce exposures, and behavioral changes such as exercise, meditation, and sleep hygiene optimization.
Sponsors
North County Natural Medicine
National University of Natural Medicine
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Community-dwelling adults ≥60 years of age. * Montreal Cognitive Assessment (MoCA) score of 12-23. * Able to independently make decisions. * Able to safely travel to North County Natural Medicine for 4 study visits and approximately 4 clinical visits, for a duration of 6 months. * Able to wear an Oura Ring, download data every 6 days, and keep the ring regularly charged for the duration of participants' involvement in the study. * A high school diploma or equivalent. * Ability to communicate via email. * Ability to independently fill out a computer-administered questionnaire. * Ability to withhold from seeing another integrative or alternative medicine provider for the 6 months of participation in the study.
Exclusion criteria
* Inability to read and write in English. * MoCA score \>23. * A visual impairment that would prevent reading a computer screen. * Partial or full deafness. * A previous diagnosis of dementia (e.g. Alzheimer's Disease or any other kind of dementia). * Congenital cognitive impairment or disability. * Alcohol or substance abuse. * Serious somatic disease, neurodegenerative disease, acute onset of cognitive decline, or rapid neurological impairment. * Inability to bring an affiliate to the Informed Consent Consultation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NIH Toolbox-Cognitive Battery | Baseline, 6 months | Change from baseline to 6 months in scores on a computer-administered cognitive function test |
| Quality of Life in Neurological Disorders questionnaire (Neuro-QoL) | Baseline, 6 months | Change from baseline to 6 months in scores on a brief, validated questionnaire that monitors the physical, mental, and social effects experienced by individuals living with neurological conditions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity | 6 months | Change from baseline to 6 months in participants' overall physical activity as measured with telemetry from a wrist-worn activity tracker |
| Event-related potential (P300) | 6 months post-baseline visit | Change from baseline to 6 months of an auditory event provoked change in electrical potential of the brain, measured noninvasively by electroencephalography (EEG) |
| Number and type of Adverse Events | From enrollment through study completion, a period of 6 months | Total number of adverse events and serious adverse events (using NIH's Common Terminology Criteria for Adverse Events version 4.0) |
| Sleep quantity | 6 months | Change from baseline to 6 months in participants' total sleep as measured with telemetry from a wrist-worn activity tracker |
| Peak alpha frequency | 6 months post-baseline visit | Change from baseline to 6 months of the peak (highest intensity) frequency in electrical activity of the brain between 8 Hz and 12 Hz, measured noninvasively by electroencephalography (EEG) |
Countries
United States
Outcome results
None listed