Mild Cognitive Impairment(MCI)NCT02943187
Multidisciplinary Intervention for Mild Cognitive Impairment
A study testing Cognitive training and Nutrition in people with Mild Cognitive Impairment, run by Gibson Institute of Cognitive Research at 1 site in United States.
Trial summary
The purpose of this investigation is to conduct a series of case studies on the impact of a novel functional medicine approach to improving cognitive skills, brain structure, and daily functioning for participants with Mild Cognitive Impairment (MCI). Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Cognitive training and Nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jun 2022
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50+ previously diagnosed with MCI
- Living in the greater Colorado Springs area
Who cannot join
- No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
United States1 site
Gibson Institute of Cognitive Research
Colorado Springs, Colorado, 80919
About this study
Official title: Novel Functional Medicine Intervention With Cognitive Training for Mild Cognitive Impairment (MCI): A Multiple Baseline Study Across Cases
The purpose of this investigation is to conduct a series of case studies on the impact of a novel functional medicine approach to improving cognitive skills, brain structure, and daily functioning for participants with Mild Cognitive Impairment (MCI).
Read the detailed description
Using a multiple baseline design across cases with start point randomization, the proposed study will examine the outcomes from a combination of optimized diet, exercise, nutritional supplements, and cognitive training across domains on standardized measures used to monitor treatment effectiveness for Mild Cognitive Impairment (MCI).
- Conditions
- Mild Cognitive Impairment
- Being tested
- Cognitive training, Nutrition
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
A clinician will deliver three 90-minute cognitive training sessions per week for 14 weeks. There are 16 different categories of leveled training procedures sequenced in intensity and difficulty for a total of 530 training tasks.
NutritionDietary supplement
Participants will be given dietary recommendations and nutritional supplements to optimize cognition.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition and Cognitive Training | Experimental | The intervention includes a physician-directed diet, exercise, and nutritional supplementation regimen, combined with a 60-hour, clinician-delivered cognitive training program created by LearningRx. Receives: Behavioral: Cognitive training; Dietary Supplement: Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of overall cognitive function improvement
Confirmed by change in pretest to post-test scores on the Dementia Rating Scale (DRS-2)
Measured: within 14 days after completing the intervention
Secondary outcomes (5)
Evidence of improvement in executive function
As confirmed by pretest to post-test changes on the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
Measured: within 14 days after completing the intervention
Evidence of improvement in cognitive flexibility
As confirmed by pretest to post-test changes on a Trail Making Test
Measured: within 14 days after completing the intervention
Evidence of change in brain function
Confirmed by change in pretest to post-test neuroimaging using MRI
Measured: within 30 days after completing the intervention
Evidence of improvement in visual attention
Confirmed by change in pretest to post-test scores on the Conners Continous Performance Test (CPT-3)
Measured: with 14 days after completing the intervention
Evidence of improvement in auditory attention
Confirmed by change in pretest to post-test scores on the Auditory Attention Test (CATA)
Measured: with 14 days after completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2018
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gibson Institute of Cognitive Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- True Life Medicine
- Responsible party
- Sponsor
- Investigators
- Christina Ledbetter, PhD, Principal investigator, Gibson Institute of Cognitive ResearchAmy L Moore, PhD, Study director, Gibson Institute of Cognitive ResearchRandolph James, MD, Principal investigator, True Life MedicineDick M Carpenter, PhD, Principal investigator, University of Colorado, Colorado Springs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943187
- Sponsor's protocol ID
- GICR-1012
- Acronym
- (MCI)
- Status last verified
- Jul 2021
- First submitted
- 21 Oct 2016
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Harvard Dataverse
Publications
James, R., Moore, A.L., Carpenter, D., Miller, T., & Ledbetter, C. (2019). Feasibility of a Functional Medicine Approach to Slowing Clinical Cognitive Decline in Patients Over Age 55: A Multiple Case Study Report. OBM Integrative and Complementary Medicine, 4(3). doi: 10.21926/obm.icm.1903054 Retrieved from https://www.lidsen.com/journals/icm/icm-04-03-054
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Functional Medicine Intervention With Cognitive Training for Mild Cognitive Impairment (MCI): A Multiple Baseline Study Across Cases
- ClinicalTrials.gov ID
- NCT02943187
- Acronym / sponsor ID
- (MCI) / GICR-1012
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Gibson Institute of Cognitive ResearchIndustry (pharma, biotech, devices)
- Collaborators
- True Life Medicine
- Study start
- Oct 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jun 2022 (estimated)
- First posted
- 24 Oct 2016 (estimated)
- 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 purpose of this investigation is to conduct a series of case studies on the impact of a novel functional medicine approach to improving cognitive skills, brain structure, and daily functioning for participants with Mild Cognitive Impairment (MCI).
Detailed description
Using a multiple baseline design across cases with start point randomization, the proposed study will examine the outcomes from a combination of optimized diet, exercise, nutritional supplements, and cognitive training across domains on standardized measures used to monitor treatment effectiveness for Mild Cognitive Impairment (MCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrition and Cognitive Training | Experimental | Behavioral: Cognitive training, Dietary Supplement: NutritionThe intervention includes a physician-directed diet, exercise, and nutritional supplementation regimen, combined with a 60-hour, clinician-delivered cognitive training program created by LearningRx. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 50+ previously diagnosed with MCI
- Living in the greater Colorado Springs area
Key exclusion criteria (1 listed)
- No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging
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 |
|---|---|---|
| Cognitive trainingA clinician will deliver three 90-minute cognitive training sessions per week for 14 weeks. There are 16 different categories of leveled training procedures sequenced in intensity and difficulty for a total of 530 training tasks. | Behavioural | Nutrition and Cognitive Training |
| NutritionParticipants will be given dietary recommendations and nutritional supplements to optimize cognition. | Dietary supplement | Nutrition and Cognitive Training |
Primary outcome
Evidence of overall cognitive function improvement
Time frame: within 14 days after completing the intervention
Confirmed by change in pretest to post-test scores on the Dementia Rating Scale (DRS-2)
5 secondary outcomes
Evidence of improvement in executive function
Time frame: within 14 days after completing the intervention
Evidence of improvement in cognitive flexibility
Time frame: within 14 days after completing the intervention
Evidence of change in brain function
Time frame: within 30 days after completing the intervention
Evidence of improvement in visual attention
Time frame: with 14 days after completing the intervention
Evidence of improvement in auditory attention
Time frame: with 14 days after completing the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Results publicationJames, R., Moore, A.L., Carpenter, D., Miller, T., & Ledbetter, C. (2019). Feasibility of a Functional Medicine Approach to Slowing Clinical Cognitive Decline in Patients Over Age 55: A Multiple Case Study Report. OBM Integrative and Complementary Medicine, 4(3). doi: 10.21926/obm.icm.1903054 Retrieved from https://www.lidsen.com/journals/icm/icm-04-03-054
- James et al study linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Harvard Dataverse
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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.
Christina Ledbetter, PhD principal investigator
Gibson Institute of Cognitive Research
Amy L Moore, PhD study director
Gibson Institute of Cognitive Research
Randolph James, MD principal investigator
True Life Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training and Nutrition in people with Mild Cognitive Impairment, run by Gibson Institute of Cognitive Research 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Jul 2021. 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?
Results are not available in the source record.
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?
Evidence of overall cognitive function improvement (time frame: within 14 days after completing the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02943187, which also lists 1 linked publication.
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 27 Jul 2021.