Clinical trial NCT04284449: Integrative Therapy for Holistic, Natural Cognition and Lifestyle Rehabilitation
Official title: Integrative Therapy for Holistic, Natural Cognition and Lifestyle Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Dysfunction
Keywords: Mild Cognitive Impairment (MCI)
Cognitive Decline
Alzheimer's Disease (AD)
Dementia
Lead sponsor: National University of Natural Medicine
Sponsor class: OTHER
Collaborators: name: North County Natural Medicine
First posted: 2020-02-25
Enrollment: 34
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults aged 60 years or more, with objectively measurable cognitive impairment, who volunteer to receive care at a specific clinic in Southern California.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: NIH Toolbox-Cognitive Battery
timeFrame: Baseline, 6 months
measure: Quality of Life in Neurological Disorders questionnaire (Neuro-QoL)
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Event-related potential (P300)
timeFrame: 6 months post-baseline visit
measure: Peak alpha frequency
timeFrame: 6 months post-baseline visit
measure: Physical activity
timeFrame: 6 months
measure: Sleep quantity
timeFrame: 6 months
measure: Number and type of Adverse Events
timeFrame: From enrollment through study completion, a period of 6 months
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: North County Natural Medicine
state: California
Study officials:
affiliation: National University of Natural Medicine
name: Ryan Bradley, ND
role: PRINCIPAL_INVESTIGATOR
affiliation: North County Natural Medicine
name: Heather Sandison, ND
role: PRINCIPAL_INVESTIGATOR
References: