Integrative Therapy for Holistic, Natural Cognition and Lifestyle Rehabilitation

NCT04284449 | Completed

• 1 other identifier: RB7102019
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction

Keywords

Mild Cognitive Impairment (MCI); Cognitive Decline; Alzheimer's Disease (AD); Dementia

Outcome Measures

Primary Outcomes (2)

• NIH Toolbox-Cognitive Battery

  Change from baseline to 6 months in scores on a computer-administered cognitive function test

  Baseline, 6 months

• Quality of Life in Neurological Disorders questionnaire (Neuro-QoL)

  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

  Baseline, 6 months

Secondary Outcomes (5)

• Event-related potential (P300)

  6 months post-baseline visit

• Peak alpha frequency

  6 months post-baseline visit

• Physical activity

  6 months

• Sleep quantity

  6 months

• Number and type of Adverse Events

  From enrollment through study completion, a period of 6 months

Study Arms (1)

Enrolled Participants

This is a whole-practice precision medicine model in which a participant-specific Naturopathic treatment program is developed and implemented for older adults with cognitive complaints.

Other: Whole-practice cognitive optimization

Interventions

Whole-practice cognitive optimization OTHER

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.

Enrolled Participants

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Natural Medicine: lead
• North County Natural Medicine: collaborator

Study Sites (1)

North County Natural Medicine

Encinitas, California, 92024, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Ryan Bradley, ND

  National University of Natural Medicine

  PRINCIPAL INVESTIGATOR

• Heather Sandison, ND

  North County Natural Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 25, 2020
• Study Start: February 24, 2020
• Primary Completion: February 1, 2023
• Study Completion: December 15, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)