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| Name | Class |
|---|---|
| True Life Medicine | UNKNOWN |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of overall cognitive function improvement | Confirmed by change in pretest to post-test scores on the Dementia Rating Scale (DRS-2) | within 14 days after completing the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | within 14 days after completing the intervention |
| Evidence of improvement in cognitive flexibility |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Ledbetter, PhD | Gibson Institute of Cognitive Research | Principal Investigator |
| Amy L Moore, PhD | Gibson Institute of Cognitive Research | Study Director |
| Randolph James, MD | True Life Medicine | Principal Investigator |
| Dick M Carpenter, PhD | University of Colorado, Colorado Springs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gibson Institute of Cognitive Research | Colorado Springs | Colorado | 80919 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
| Label | URL |
|---|---|
| James et al study link | View source |
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Harvard Dataverse
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Nutrition | Dietary Supplement | Participants will be given dietary recommendations and nutritional supplements to optimize cognition. |
|
As confirmed by pretest to post-test changes on a Trail Making Test |
| within 14 days after completing the intervention |
| Evidence of change in brain function | Confirmed by change in pretest to post-test neuroimaging using MRI | 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) | 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) | with 14 days after completing the intervention |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |