Cognitive DysfunctionITHNCLRNCT04284449
Integrative Therapy for Holistic, Natural Cognition and Lifestyle Rehabilitation
An observational study of Cognitive Dysfunction, run by National University of Natural Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- Whole-practice cognitive optimization
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2020to 15 Dec 2023
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
North County Natural Medicine
Encinitas, California, 92024
About this study
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.
Read the 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.
- Conditions
- Cognitive Dysfunction
- Being tested
- Whole-practice cognitive optimization
- Keywords
- Mild Cognitive Impairment (MCI), Cognitive Decline, Alzheimer's Disease (AD), Dementia
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-practice cognitive optimizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Whole-practice cognitive optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH Toolbox-Cognitive Battery
Change from baseline to 6 months in scores on a computer-administered cognitive function test
Measured: 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
Measured: Baseline, 6 months
Secondary outcomes (5)
Event-related potential (P300)
Change from baseline to 6 months of an auditory event provoked change in electrical potential of the brain, measured noninvasively by electroencephalography (EEG)
Measured: 6 months post-baseline visit
Peak alpha frequency
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)
Measured: 6 months post-baseline visit
Physical activity
Change from baseline to 6 months in participants' overall physical activity as measured with telemetry from a wrist-worn activity tracker
Measured: 6 months
Sleep quantity
Change from baseline to 6 months in participants' total sleep as measured with telemetry from a wrist-worn activity tracker
Measured: 6 months
Number and type of Adverse Events
Total number of adverse events and serious adverse events (using NIH's Common Terminology Criteria for Adverse Events version 4.0)
Measured: From enrollment through study completion, a period of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start24 Feb 2020
- Primary completion1 Feb 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- North County Natural Medicine
- Responsible party
- Principal investigator, Ryan Bradley, National University of Natural Medicine
- Investigators
- Ryan Bradley, ND, Principal investigator, National University of Natural MedicineHeather Sandison, ND, Principal investigator, North County Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284449
- Sponsor's protocol ID
- RB7102019
- Acronym
- ITHNCLR
- Status last verified
- Aug 2024
- First submitted
- 12 Feb 2020
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Therapy for Holistic, Natural Cognition and Lifestyle Rehabilitation
- ClinicalTrials.gov ID
- NCT04284449
- Acronym / sponsor ID
- ITHNCLR / RB7102019
- Conditions
- Cognitive Dysfunction
- Keywords
- Mild Cognitive Impairment (MCI), Cognitive Decline, Alzheimer's Disease (AD), Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Collaborators
- North County Natural Medicine
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 25 Feb 2020 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled Participants | – | Other: Whole-practice cognitive optimizationThis 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
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 |
|---|---|---|
| Whole-practice cognitive optimizationThis 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. | Other | Enrolled Participants |
Primary outcome
NIH Toolbox-Cognitive Battery
Time frame: 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)
Time frame: 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
5 secondary outcomes
Event-related potential (P300)
Time frame: 6 months post-baseline visit
Peak alpha frequency
Time frame: 6 months post-baseline visit
Physical activity
Time frame: 6 months
Sleep quantity
Time frame: 6 months
Number and type of Adverse Events
Time frame: From enrollment through study completion, a period of 6 months
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 6 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Ryan Bradley, ND principal investigator
National University of Natural Medicine
Heather Sandison, ND principal investigator
North County Natural Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Dysfunction, run by National University of Natural Medicine at 1 site 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 9 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 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
NIH Toolbox-Cognitive Battery (time frame: Baseline, 6 months). The study lists 2 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 6 Aug 2024.